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LEO Pharma today announced that it received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for brodalumab, a novel biologic treatment for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.[1] Brodalumab is the only fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A.[2],[3] By binding to the receptor with high affinity, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis.[3],[4] Brodalumab is not currently licensed in the EU. The positive opinion from the CHMP is supported by data from three clinical trials, AMAGINE-1 (n=661), AMAGINE-2 (n=1831) and AMAGINE-3 (n=1881), with a total of 4,373 patients with moderate to severe psoriasis;[5],[6] the largest study population of any new biologic treatment in psoriasis to date.[7],[8],[9],[10],[11],[12],[13] All three studies evaluated the efficacy and safety of different doses of brodalumab compared to placebo.[5],[6] AMAGINE-2 and AMAGINE-3 also compared brodalumab to ustekinumab.[5] Results showed brodalumab offered many patients complete skin clearance (PASI 100) at 12 weeks compared to patients treated with ustekinumab [AMAGINE-2: 44% (n=272) versus 22% (n=65), p<0.001; AMAGINE-3: 37% (n=229) versus 19% (n=58), p<0.001].[5]In AMAGINE-1 83% of patients on brodalumab 210mg achieved PASI 75[*] compared to 3% of patients treated with placebo at 12 weeks [83.3% (n=185) versus 2.7% (n=6), p<0.001] and 76% of patients achieved sPGA[†] success versus 1% of patients treated with placebo [75.7% (n=168) versus 1.4% (n=3), p<0.001].[6] High levels of skin clearance were sustained with continuous brodalumab treatment through week 52.[6],[14] "Brodalumab works by blocking the pro-inflammatory cascade that leads to psoriasis, resulting in normalisation of skin inflammation. In the brodalumab clinical trials, the majority of patients achieve clear or almost clear skin within 3 months of treatment as measured by the psoriasis area and severity index (PASI) 100 or 90. In real terms, this means that patients get to the point where their psoriasis no longer bothers them and this is the ultimate treatment goal," commented Professor Kristian Reich, Dermatologist and Principal Investigator of the AMAGINE Phase 3 clinical trials programme for brodalumab, Hamburg, Germany. Patients also reported experiencing improved health related quality of life after 4 weeks of treatment with brodalumab. After 12 weeks of treatment, seven in ten patients (72%, n=29/40, p<0.0001) reported psoriasis no longer impaired their health related quality of life, (0/1 DLQI) compared with placebo (5%, n=2/37).[15] "It is critical that people with psoriasis have the necessary tools and support to help them get through life as unhindered by their condition as possible and don't feel it controls their life. At LEO Pharma we are committed to improving the lives of people with skin conditions, and this positive opinion from the CHMP takes us one step closer to being able to do exactly that for the people who matter most to us. The evidence for brodalumab demonstrates real promise and we hope that we can provide not only a new treatment option, but also the opportunity to help people living with moderate-to-severe psoriasis to take control of their condition and improve their lives significantly," says Kim Domela Kjøller, Executive Vice President of Global Research and Development at LEO Pharma. Data from the three large randomised, controlled AMAGINE clinical trials, found brodalumab to be well tolerated, with an acceptable safety profile.[6],[16] The most common adverse events were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx), headache, and upper respiratory tract infection.[5] Cases of suicidal ideation and behaviour, including completed suicide, were reported in the clinical trials programme.[17] A causal association between treatment with brodalumab and increased risk of suicidal ideation and behaviour has not been established.[17] Brodalumab will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events. The CHMP's recommendation will now be referred to the European Commission, which has the authority to approve medicines for use in all EU countries. This announcement follows the approval of brodalumab by the U.S. Food and Drug Administration for plaque psoriasis in February 2017; and the approval by the Japanese Pharmaceuticals and Medical Devices Agency for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma in 2016. *. PASI 75 is defined ≥ 75% improvement in Psoriasis Area and Severity Index score †. sPGA success is defined as patients who achieved a static Physician's Global Assessment 0 or 1 Brodalumab is the only fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A.[2],[3] By binding to the receptor with high affinity, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis.[3],[4] Brodalumab is not currently licensed in the EU. In July 2016, LEO Pharma entered into a partnership agreement with AstraZeneca granting LEO exclusive licence to develop and commercialise brodalumab in Europe. Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co., Ltd. LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide. An estimated 125 million people worldwide live with psoriasis,[18] including nearly 14 million Europeans.[19] While there are several types of psoriasis, of which plaque psoriasis is most common affecting up to 97% of patients, the most frequently reported symptoms include thickening and scaling of the skin, itching and erythema (superficial reddening of the skin, usually in patches).[20] Psoriasis can be a painful, disabling and stigmatising condition with substantial social and psychological impact on a person's life.[20] Although the systemic nature of psoriasis often remains unrecognised, the inflammatory processes involved may be associated with the development of comorbidities[21] such as cardiovascular and metabolic diseases which are more prevalent in people with moderate-to-severe psoriasis.[22],[23] Research shows that people with moderate-to-severe psoriasis have a two to three-fold risk of anxiety, depression and suicidal behaviour compared to the general public.[24] According to the World Health Organization, the burden of living with psoriasis is underestimated and it urges for action to fight stigma and improve treatment.[20] 1. European Medicines Agency, 18 May 2017. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003959/smops/Positive/human_smop_001146.jsp&mid=WC0b01ac058001d127     2. Campa M, et al. Dermatol Ther. 2016;6:1-12    3. Coimbra S, et al. Core Evidence. 2014;9:89-97    4. Papp K, et al. N Engl J Med 2012;336:1181-9    5. Lebwohl M, et al. N Engl J Med 2015;373:1318-28    6. Papp K, et al. Br J Dermatol. 2016;175:273-286     7. European Medicines Agency. EPAR summary for the public: Cosentyx. 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003729/WC500183132.pdf (Accessed May 2017)    8. Taltz®. Summary of Product Characteristics 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003943/WC500205804.pdf (Accessed May 2017)    9. Stelara®. Summary of Product Characteristics 2009. Available from: https://www.medicines.org.uk/emc/medicine/32569 (Accessed May 2017)    10. Enbrel®. Summary of Product Characteristics 2000. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000262/WC500027361.pdf (Accessed May 2017)    11. Humira®. Summary of Product Charateristics 2003. Available from: https://www.medicines.org.uk/emc/medicine/31860 (Accessed May 2017)    12. Remicade®. Summary of Product Characteristics 1999. Available from:  http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf (Accessed May 2017)   13. National Institute for Health and Care Excellence (NICE) Psoriasis: assessment and management guidelines. Available at: https://www.nice.org.uk/guidance/cg153/chapter/1-Guidance#systemic-therapy   (Accessed May 2017)   14. Supplement to: Lebwohl M, et al. N Engl J Med. 2015;373:1318-28   15. Gordon KB, et al. Br J Dermatol. 2014;170:705-15    16. Attia A, et al. Clin Drug Investig. 2017; DOI: 10.1007/s40261-017-0500-9    17. Lebwohl, M. et al. The American Academy of Dermatology annual meeting 2017. Poster 4908   18. The International Federation of Psoriasis Associations. World Psoriasis Day. Available from: https://ifpa-pso.com/our-actions/world-psoriasis-day/  (Accessed May 2017) 19. Ortonne J, et al. Eur J Dermatol. 2004;14:41-45   20. World Health Organization (WHO). Global Report on Psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf  (Accessed May 2017)   21. Reich K.  Eur Acad Dermatol Venereol. 2012; 26(2):3-11   22. Kimball AB, et al. Br J Dermatol. 2014;171(1):137-147   23. Feldman S, et al. J Man Care and Specialty Pharm. 2015;21(10):874-888  24. Dalgard F, et al. JID. 2015;135(4), 984-991 


Merck, a leading science and technology company, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has authorized Glucophage® SR (sustained release formulation; metformin), for the reduction in the risk or delay of the onset of type 2 diabetes in adult, overweight patients with impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG), and/or increased glycated hemoglobin (HbA1c), when intensive lifestyle changes for 3 to 6 months have failed. This condition is referred to by a variety of names in medical guidelines, i.e. as non-diabetic hyperglycemia, as impaired glucose regulation, or as pre-diabetes.[1],[4]-[7] Merck has already received authorization for this indication in several countries around the world. Through earlier intervention, patients can reduce their risk of developing type 2 diabetes[8] as well as complications that can lead to serious health issues.[5] "We are pleased that patients at risk of diabetes in the UK now have a medicinal treatment option to help them delay the onset of diabetes, when intensive lifestyle changes alone are not enough to work against the progression to type 2 diabetes," said Luciano Rossetti MD, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck: "According to WHO, diabetes is considered a global pandemic and we are committed to helping slow the rapidly growing incidence. This is an important achievement as it can help play a role in reducing the burden of type 2 diabetes for patients." The authorization is based on clinical data on the efficacy of Glucophage® for the treatment of non-diabetic hyperglycemia, primarily gathered in the large US Diabetes Prevention Program (DPP)[8] and subsequent Diabetes Prevention Program Outcome Study (DPPOS)[9]-[11] with Glucophage®. This data was complemented by comprehensive safety and efficacy data on Glucophage® collected since its first use in patients in 1957. Non-diabetic hyperglycemia is triggered by insulin resistance, that causes cells to be unable to effectively utilize insulin, which is needed to get the glucose inside the cells and to stabilize blood glucose levels. This is also called impaired glucose tolerance (IGT). As a response, more insulin may be produced, which may again lose efficacy over time. Eventually, blood glucose levels in the body rise to higher than normal values even between meals, which is called impaired fasting glucose (IFG). Elevated blood glucose levels are also often measured as an average over time through HbA1c. The corresponding lab values for diagnosis of non-diabetic hyperglycemia as per UK's National Institute for Health and Care Excellence (NICE) guidelines, are fasting glucose between 100 and 125 mg/dl, and/or 140 to 199mg/dl in a glucose tolerance test, and/or HbA1c between 6.0 and 6.4%.[1] From this stage of non-diabetic hyperglycemia, the disease may then further slowly progress to overt type 2 diabetes. Intensive lifestyle changes will be used as a first counter action. If the patient is still at high risk of progression to type 2 diabetes after 3 to 6 months with worsening glycemic control despite intensive lifestyle measures, Glucophage® SR is now an additional treatment option that may help to slow the deterioration of the blood glucose levels. Treatment with Glucophage® SR must be based on a risk score incorporating appropriate measures of glycemic control and including evidence of high cardiovascular risk. A benefit in the reduction of risk or delay of the onset of type 2 diabetes has not yet been established in patients 75 years and older. Glucophage® (metformin hydrochloride) is a prescription-only medicine indicated for the treatment of type 2 diabetes mellitus, particularly in overweight patients when diet and exercise alone have failed. In adults, Glucophage® may be given alone or with oral antidiabetic agents, or with insulin. The most commonly reported side effects with Glucophage® SR are gastro-intestinal disturbances that may occur during treatment initiation and resolve spontaneously in most cases. The Glucophage® product portfolio comprises: Glucophage® IR (immediate release formulation) and Glucophage® SR (sustained release formulation). Outside of the UK, Glucophage® SR is known as Glucophage® XR (extended release). In addition, Merck produces Glucovance® a fixed dose combination of metformin and glibenclamide. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.


Not intended for U.S. based media Merck, a leading science and technology company, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has authorized Glucophage® SR (sustained release formulation; metformin), for the reduction in the risk or delay of the onset of type 2 diabetes in adult, overweight patients with impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG), and/or increased glycated hemoglobin (HbA1c), when intensive lifestyle changes for 3 to 6 months have failed. This condition is referred to by a variety of names in medical guidelines, i.e. as non-diabetic hyperglycemia, as impaired glucose regulation, or as pre-diabetes.[1],[4]-[7] Merck has already received authorization for this indication in several countries around the world. Through earlier intervention, patients can reduce their risk of developing type 2 diabetes[8] as well as complications that can lead to serious health issues.[5] "We are pleased that patients at risk of diabetes in the UK now have a medicinal treatment option to help them delay the onset of diabetes, when intensive lifestyle changes alone are not enough to work against the progression to type 2 diabetes," said Luciano Rossetti MD, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck: "According to WHO, diabetes is considered a global pandemic and we are committed to helping slow the rapidly growing incidence. This is an important achievement as it can help play a role in reducing the burden of type 2 diabetes for patients." The authorization is based on clinical data on the efficacy of Glucophage® for the treatment of non-diabetic hyperglycemia, primarily gathered in the large US Diabetes Prevention Program (DPP)[8] and subsequent Diabetes Prevention Program Outcome Study (DPPOS)[9]-[11] with Glucophage®. This data was complemented by comprehensive safety and efficacy data on Glucophage® collected since its first use in patients in 1957. Non-diabetic hyperglycemia is triggered by insulin resistance, that causes cells to be unable to effectively utilize insulin, which is needed to get the glucose inside the cells and to stabilize blood glucose levels. This is also called impaired glucose tolerance (IGT). As a response, more insulin may be produced, which may again lose efficacy over time. Eventually, blood glucose levels in the body rise to higher than normal values even between meals, which is called impaired fasting glucose (IFG). Elevated blood glucose levels are also often measured as an average over time through HbA1c. The corresponding lab values for diagnosis of non-diabetic hyperglycemia as per UK's National Institute for Health and Care Excellence (NICE) guidelines, are fasting glucose between 100 and 125 mg/dl, and/or 140 to 199mg/dl in a glucose tolerance test, and/or HbA1c between 6.0 and 6.4%.[1] From this stage of non-diabetic hyperglycemia, the disease may then further slowly progress to overt type 2 diabetes. Intensive lifestyle changes will be used as a first counter action. If the patient is still at high risk of progression to type 2 diabetes after 3 to 6 months with worsening glycemic control despite intensive lifestyle measures, Glucophage® SR is now an additional treatment option that may help to slow the deterioration of the blood glucose levels. Treatment with Glucophage® SR must be based on a risk score incorporating appropriate measures of glycemic control and including evidence of high cardiovascular risk. A benefit in the reduction of risk or delay of the onset of type 2 diabetes has not yet been established in patients 75 years and older. Glucophage® (metformin hydrochloride) is a prescription-only medicine indicated for the treatment of type 2 diabetes mellitus, particularly in overweight patients when diet and exercise alone have failed. In adults, Glucophage® may be given alone or with oral antidiabetic agents, or with insulin. The most commonly reported side effects with Glucophage® SR are gastro-intestinal disturbances that may occur during treatment initiation and resolve spontaneously in most cases. The Glucophage® product portfolio comprises: Glucophage® IR (immediate release formulation) and Glucophage® SR (sustained release formulation). Outside of the UK, Glucophage® SR is known as Glucophage® XR (extended release). In addition, Merck produces Glucovance® a fixed dose combination of metformin and glibenclamide. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.


Insulin wird benötigt, um Glukose aus dem Blut in das Zellinnere zu bringen und so die Blutzuckerspiegel zu stabilisieren. Die nichtdiabetische Hyperglykämie beginnt mit einer sogenannten Insulinresistenz. Hierbei können die Körperzellen der betroffenen Patienten Insulin nicht effektiv verwerten. Diese Beeinträchtigung wird auch als eingeschränkte Glukosetoleranz bezeichnet. Als Reaktion produziert der Körper mehr Insulin, das mit der Zeit ebenfalls an Wirksamkeit verlieren kann und letztendlich dazu führen kann, dass die Blutzuckerwerte im Körper sogar zwischen den Mahlzeiten nicht mehr auf den Normalwert absinken können: Der Nüchtern-Glukosewert ist erhöht. Erhöhte Blutzuckerspiegel werden häufig auch über den HbA1c als zeitliche Durchschnittswerte gemessen. Die entsprechenden Laborwerte für die Diagnose einer nichtdiabetischen Hyperglykämie sind laut Richtlinien des britischen National Institute for Health and Care Excellence (NICE) ein Nüchternglukosewert zwischen 100 und 125 mg/dl, ein Glukosetoleranztest mit Werten zwischen 140 und 199 mg/dl und/oder ein HbA1c zwischen 6,0 und 6,4%.[2] Glucophage® (Metforminhydrochlorid) ist ein verschreibungspflichtiges Medikament zur Behandlung von Typ-2-Diabetes vor allem bei übergewichtigen Patienten, bei denen Diätmaßnahmen und körperliche Betätigung allein nicht ausgereicht haben. Bei Erwachsen kann Glucophage® in Form einer Monotherapie oder in Kombination mit anderen oralen Antidiabetika bzw. Insulin angewendet werden. Zu den am häufigsten berichteten Nebenwirkungen von Glucophage® SR zählen gastrointestinale Störungen, die besonders zu Beginn der Therapie auftreten können und in den meisten Fällen spontan abklingen.


LEO Pharma today announced that it received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for brodalumab, a novel biologic treatment for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.[1] Brodalumab is the only fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A.[2],[3] By binding to the receptor with high affinity, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis.[3],[4] Brodalumab is not currently licensed in the EU. The positive opinion from the CHMP is supported by data from three clinical trials, AMAGINE-1 (n=661), AMAGINE-2 (n=1831) and AMAGINE-3 (n=1881), with a total of 4,373 patients with moderate to severe psoriasis;[5],[6] the largest study population of any new biologic treatment in psoriasis to date.[7],[8],[9],[10],[11],[12],[13] All three studies evaluated the efficacy and safety of different doses of brodalumab compared to placebo.[5],[6] AMAGINE-2 and AMAGINE-3 also compared brodalumab to ustekinumab.[5] Results showed brodalumab offered many patients complete skin clearance (PASI 100) at 12 weeks compared to patients treated with ustekinumab [AMAGINE-2: 44% (n=272) versus 22% (n=65), p<0.001; AMAGINE-3: 37% (n=229) versus 19% (n=58), p<0.001].[5]In AMAGINE-1 83% of patients on brodalumab 210mg achieved PASI 75[*] compared to 3% of patients treated with placebo at 12 weeks [83.3% (n=185) versus 2.7% (n=6), p<0.001] and 76% of patients achieved sPGA[†] success versus 1% of patients treated with placebo [75.7% (n=168) versus 1.4% (n=3), p<0.001].[6] High levels of skin clearance were sustained with continuous brodalumab treatment through week 52.[6],[14] "Brodalumab works by blocking the pro-inflammatory cascade that leads to psoriasis, resulting in normalisation of skin inflammation. In the brodalumab clinical trials, the majority of patients achieve clear or almost clear skin within 3 months of treatment as measured by the psoriasis area and severity index (PASI) 100 or 90. In real terms, this means that patients get to the point where their psoriasis no longer bothers them and this is the ultimate treatment goal," commented Professor Kristian Reich, Dermatologist and Principal Investigator of the AMAGINE Phase 3 clinical trials programme for brodalumab, Hamburg, Germany. Patients also reported experiencing improved health related quality of life after 4 weeks of treatment with brodalumab. After 12 weeks of treatment, seven in ten patients (72%, n=29/40, p<0.0001) reported psoriasis no longer impaired their health related quality of life, (0/1 DLQI) compared with placebo (5%, n=2/37).[15] "It is critical that people with psoriasis have the necessary tools and support to help them get through life as unhindered by their condition as possible and don't feel it controls their life. At LEO Pharma we are committed to improving the lives of people with skin conditions, and this positive opinion from the CHMP takes us one step closer to being able to do exactly that for the people who matter most to us. The evidence for brodalumab demonstrates real promise and we hope that we can provide not only a new treatment option, but also the opportunity to help people living with moderate-to-severe psoriasis to take control of their condition and improve their lives significantly," says Kim Domela Kjøller, Executive Vice President of Global Research and Development at LEO Pharma. Data from the three large randomised, controlled AMAGINE clinical trials, found brodalumab to be well tolerated, with an acceptable safety profile.[6],[16] The most common adverse events were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx), headache, and upper respiratory tract infection.[5] Cases of suicidal ideation and behaviour, including completed suicide, were reported in the clinical trials programme.[17] A causal association between treatment with brodalumab and increased risk of suicidal ideation and behaviour has not been established.[17] Brodalumab will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events. The CHMP's recommendation will now be referred to the European Commission, which has the authority to approve medicines for use in all EU countries. This announcement follows the approval of brodalumab by the U.S. Food and Drug Administration for plaque psoriasis in February 2017; and the approval by the Japanese Pharmaceuticals and Medical Devices Agency for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma in 2016. *. PASI 75 is defined ≥ 75% improvement in Psoriasis Area and Severity Index score †. sPGA success is defined as patients who achieved a static Physician's Global Assessment 0 or 1 Brodalumab is the only fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A.[2],[3] By binding to the receptor with high affinity, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis.[3],[4] Brodalumab is not currently licensed in the EU. In July 2016, LEO Pharma entered into a partnership agreement with AstraZeneca granting LEO exclusive licence to develop and commercialise brodalumab in Europe. Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co., Ltd. LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide. An estimated 125 million people worldwide live with psoriasis,[18] including nearly 14 million Europeans.[19] While there are several types of psoriasis, of which plaque psoriasis is most common affecting up to 97% of patients, the most frequently reported symptoms include thickening and scaling of the skin, itching and erythema (superficial reddening of the skin, usually in patches).[20] Psoriasis can be a painful, disabling and stigmatising condition with substantial social and psychological impact on a person's life.[20] Although the systemic nature of psoriasis often remains unrecognised, the inflammatory processes involved may be associated with the development of comorbidities[21] such as cardiovascular and metabolic diseases which are more prevalent in people with moderate-to-severe psoriasis.[22],[23] Research shows that people with moderate-to-severe psoriasis have a two to three-fold risk of anxiety, depression and suicidal behaviour compared to the general public.[24] According to the World Health Organization, the burden of living with psoriasis is underestimated and it urges for action to fight stigma and improve treatment.[20] 1. European Medicines Agency, 18 May 2017. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003959/smops/Positive/human_smop_001146.jsp&mid=WC0b01ac058001d127     2. Campa M, et al. Dermatol Ther. 2016;6:1-12    3. Coimbra S, et al. Core Evidence. 2014;9:89-97    4. Papp K, et al. N Engl J Med 2012;336:1181-9    5. Lebwohl M, et al. N Engl J Med 2015;373:1318-28    6. Papp K, et al. Br J Dermatol. 2016;175:273-286     7. European Medicines Agency. EPAR summary for the public: Cosentyx. 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003729/WC500183132.pdf (Accessed May 2017)    8. Taltz®. Summary of Product Characteristics 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003943/WC500205804.pdf (Accessed May 2017)    9. Stelara®. Summary of Product Characteristics 2009. Available from: https://www.medicines.org.uk/emc/medicine/32569 (Accessed May 2017)    10. Enbrel®. Summary of Product Characteristics 2000. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000262/WC500027361.pdf (Accessed May 2017)    11. Humira®. Summary of Product Charateristics 2003. Available from: https://www.medicines.org.uk/emc/medicine/31860 (Accessed May 2017)    12. Remicade®. Summary of Product Characteristics 1999. Available from:  http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf (Accessed May 2017)   13. National Institute for Health and Care Excellence (NICE) Psoriasis: assessment and management guidelines. Available at: https://www.nice.org.uk/guidance/cg153/chapter/1-Guidance#systemic-therapy   (Accessed May 2017)   14. Supplement to: Lebwohl M, et al. N Engl J Med. 2015;373:1318-28   15. Gordon KB, et al. Br J Dermatol. 2014;170:705-15    16. Attia A, et al. Clin Drug Investig. 2017; DOI: 10.1007/s40261-017-0500-9    17. Lebwohl, M. et al. The American Academy of Dermatology annual meeting 2017. Poster 4908   18. The International Federation of Psoriasis Associations. World Psoriasis Day. Available from: https://ifpa-pso.com/our-actions/world-psoriasis-day/  (Accessed May 2017) 19. Ortonne J, et al. Eur J Dermatol. 2004;14:41-45   20. World Health Organization (WHO). Global Report on Psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf  (Accessed May 2017)   21. Reich K.  Eur Acad Dermatol Venereol. 2012; 26(2):3-11   22. Kimball AB, et al. Br J Dermatol. 2014;171(1):137-147   23. Feldman S, et al. J Man Care and Specialty Pharm. 2015;21(10):874-888  24. Dalgard F, et al. JID. 2015;135(4), 984-991 


A new technology -- 'dialysis for the lungs' -- which could save thousands of lives in Intensive Care Units is being taken forward by researchers at Queen's University Belfast in one of the biggest clinical trials in the world in the area of respiratory failure. Queen's researchers and Belfast Health and Social Care Trust are co-leading the landmark trial involving 1,120 critically ill patients in 40 different hospital sites across the UK over the next four years. Recruited patients will test the effectiveness of a new procedure designed to alleviate the pressure put on the lungs by mechanical ventilation -- or 'ventilators'. Researchers believe the new procedure -- which removes carbon dioxide from the blood in a process similar to kidney dialysis -- can significantly improve survival rates in people suffering respiratory failure but only a full trial will provide evidence. Respiratory failure is common in the UK; about 100,000 people each year require ventilators and up to 40% of these patients ultimately die. In Northern Ireland, around 600 people require ventilators with approximately 240 deaths. The number of deaths exceeds that from road traffic accidents or from common cancers such as prostate cancer. Although ventilators save lives, they are also linked with damage to the lungs, because of the pressure exerted. The new technology being trialled by Queen's and Belfast Trust is called 'extracorporeal carbon dioxide removal' and allows for a gentler ventilation. Queen's and Belfast Trust medics completed a pilot trial last year, across 10 UK sites, which demonstrated that the procedure was safe and did facilitate gentler ventilation. The full trial will concentrate on how significantly it can impact mortality rates. Professor Danny McAuley, Professor of Intensive Care Medicine at the Wellcome-Wolfson Institute for Experimental Medicine at Queen's University Belfast, explained: "A mechanical ventilator acts like bellows as air is forced into the lungs under pressure. If the pressure is too high, this can cause lasting damage. "These new devices, however, have been designed to help remove carbon dioxide from the patient's blood - in a process quite similar to kidney dialysis -- which is one of the main functions of the lungs. By temporarily removing this function from the lungs, it means lungs do not have to work quite as hard, so a gentler ventilation should be sufficient. "Recent National Institute for Health and Care Excellence (NICE) guidelines have encouraged clinicians in the UK to recruit patients to our trial which is a great endorsement of what we are doing here at Queen's." Dr James McNamee, from Belfast Health and Social Care Trust said: "In our study, there will be two groups of people admitted to ICUs with respiratory failure. One will receive the best level of care within current NHS guidelines while the other group will have the additional, new treatment to artificially remove the carbon dioxide from their blood. At the end, we should know whether the new technology can significantly impact on mortality rates." The extracorporeal CO2 removal device to be used in the study, called the Hemolung Respiratory Assist System, is manufactured by US-based ALung Technologies. Peter DeComo, Chief Executive Officer of ALung said: "We are excited to see the study proceed from the pilot to pivotal stage. We applaud Professor McAuley and his team for their efforts and obtainment of this important milestone." The £2.1million research project, including the pilot trial, is being funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme. Dr Janice Bailie, Assistant Director of the Public Health Agency's Health and Social Care R&D Division in Northern Ireland, which has provided long-term support to help the Northern Ireland team secure the award said: "I am delighted that Northern Ireland will lead this UK-wide research study that has the potential to improve the management of patients in critical care worldwide. "The prestigious National Institute for Health Research offers the opportunity for local researchers like Professor McAuley and his team to bring major research income to Northern Ireland, to support this type of study. The results of this study will be of interest at an international level and will highlight the capability of Northern Ireland researchers to lead globally significant healthcare research".


News Article | April 26, 2017
Site: www.prweb.com

The European Patent Office (EPO) today announced that Waleed Hassanein, M.D., president and CEO of TransMedics, Inc., of Andover, Mass., has been named a finalist for the European Inventor Award 2017 in the category of “Non-European countries.” The winners of the 12th edition of the EPO’s annual innovation prize will be announced at a ceremony held on June 15th at the Arsenale di Venezia in Venice, Italy. For many decades, donor organs were preserved by storing them on ice while en route to transplant recipients. This method, known as cold ischemia, significantly limits the time span before organs suffer severe cold-related damage – only three to four hours for a human heart – and may also increase postoperative complications. A new approach changes the paradigm: U.S. Cardiac Surgeon Waleed Hassanein (48) developed a process for preserving donor organs outside the human body up to three times as long as in cold storage. Released into clinical practice in 2007 as the Organ Care System (OCS), the invention has already been used in over 800 successful organ transplants. It is covered by dozens of patents. “Hassanein’s ‘living organ’ technology offers a new approach to preserving organs for transplantation, and fresh hope for transplant recipients,” said EPO President Benoît Battistelli announcing the European Inventor Award 2017 finalists. "The invention could replace a decades-old method in clinical practice and has already helped to launch a successful company." Hassanein began working on his breakthrough as a young resident doctor at Georgetown University in the early 1990s. During his first heart transplant, Hassanein was shocked to see a potentially life-saving organ placed in cold storage. "When I saw a human heart, the organ I was trained to protect, being placed inside what was essentially a picnic cooler, I knew there had to be a better way," says Hassanein. He began experimenting with keeping the organs in a warm environment, surrounded by nutrient-rich blood. This provided the fundamental insights behind the Organ Care System (OCS). Originally developed for storing human hearts, the OCS platform now also supports lungs and kidneys. The system could have significant potential in transplant surgery: It allows clinicians to inspect organs during storage for damage or even treat infections outside of the body – something impossible during cold ischemia. Successful OCS heart transplants have been made after up to 11 hours of receipt of the organ. Behind OCS technology lies a fundamentally new approach to ex vivo (out of body) organ preservation. While storing organs on ice only serves to slow down its inevitable death, Hassanein's method prolongs the organ's life while it is being transported to a recipient. "The system enables donor organs to remain in a near-physiological and functioning state outside the human body. Hearts keep beating, lungs breathing, livers producing bile and kidneys producing urine," says Hassanein. To do so, OCS replicates human functions and continuously supports donor organs with warm, oxygenated blood through a so-called "perfusion system" inside a clear, sterile, temperature-controlled chamber. Loaded with pumps, ventilation systems, and control sensors, the devices are the size of small refrigerators. They can be wheeled on board ambulance vehicles and rescue helicopters, adding crucial hours in a "race against the clock" when bringing donor organs to their destination. Around the world, several hundred thousand patients are currently waiting for life-saving organ transplants, around 120,000 in the U.S., and roughly 86,000 patients in the EU and some neighboring countries, such as Iceland, Norway and Turkey. But due to the limitations of cold storage, only one in three donated hearts can be used for transplants. In the U.S., for example, 22 people die each day while awaiting a transplant. OCS expands the pool of available organs by allowing for prolonged out-of-body storage, which in turn means donor organs can be transported over longer distances, and by enabling doctors to evaluate and assess organs ‘suitability for transplant while in storage, which was not possible before. The system also reduces a serious post-transplant complication called Primary Graft Dysfunction (PGD) – during which the body rejects the new organ – with 50% fewer PGD cases than cold storage. Widespread adoption of OCS could create an end-to-end live organ storage network between donors, clinics, and recipients. As a first step, the UK's National Institute for Health and Care Excellence (NICE) has issued a recommendation for clinical use of the OCS Heart system in 2016. Looking ahead, the inventor believes that OCS technology also holds the potential to unlock "out of body" chemotherapy, genetic therapy and regenerative medicine. "We are utterly convinced that the Organ Care System is going to transform organ transplantation and provide more and better organs for very sick patients in need of these transplants," says Hassanein. In order to market his patented inventions, Hassanein founded Massachusetts-based start-up company TransMedics in 1998. So far, the company has received roughly EUR 280 million in venture and private equity capital and employs 70 people. As of today, the OCS technology platform – consisting of the OCS Lung, OCS Heart and OCS Liver systems – is CE-marked in the EU and approved in Australia and Canada, while FDA-approval is pending in the US. Analysts expect this invention to have a significant impact on the medical technology market, which could reach EUR 189 million as early as 2019. Born and raised in a suburb of Cairo, Egypt, Waleed Hassanein has always set his sights on lofty goals: As a young man, he wanted to become an airplane pilot, but a family legacy of successful physicians saw him headed into medicine. After immigrating to the United States in 1990 – he is now a U.S. citizen – the inventor earned his MD in medicine from the Georgetown University School of Medicine in Washington, D.C., in 1993. It was here that the cardiac surgeon decided to improve the prospects of organ recipients with his methods. Today, Waleed Hassanein serves as the CEO, President, and Director of TransMedics, the start-up company he created to market his entirely new concept of "living organ transplants" that he hopes will change clinical practice. "We are no longer fighting against the clock, because the organ is living outside of the human body. So theoretically speaking, this organ can stay alive in our system for a day or two, maybe even longer. Basically, we can transform a transplant from an emergency procedure into a scheduled procedure," says Hassanein, who is currently expanding the technology to accommodate even more types of organs. Video and photo material Read more about the inventor Waleed Hassanein is not the only inventor nominated for an invention that increases the chances of survival for recipients of donor organs at this year's award. In the Industry category, Italian nephrologist Giuseppe Remuzzi is a finalist for inventing medications that use angiotensin-converting-enzyme (ACE) to prevent kidney failure after organ transplants. Read more about the future of medicine.


News Article | April 28, 2017
Site: www.chromatographytechniques.com

The UK’s Cancer Drugs Fund, established by the government in 2010 to cover the costs of expensive medicines not available by the National Institute for Health and Care Excellence (NICE), was not beneficial for patients or society, and in some cases may have even caused “unnecessary” suffering, according to a report published in the Annals of Oncology. The CDF had an initial budget of £50 million per year, with the intent to move toward a value-based pricing plan by 2014. But the Fund spent £1.3 billion in taxpayer money from 2010 to 2016, the equivalent of one year’s total spend on all cancer drugs in the National Health Service, according to the analysis. The goal of the program was to improve patients’ access to cancer drugs and reduce delays in NICE’s drug approval process. The drugs chosen for reimbursement through the CDF were not available through NHS for several reasons – the drugs had yet to be appraised, were in the process of being appraised, or were appraised but not recommended by NICE. The study authors analyzed the potential value delivered by the CDF using six criteria points, including cost-effectiveness, trial evidence of drug efficacy and observational studies assessing a drug’s effectiveness in “real-world” populations, among others. The analysis focused on 29 cancer drugs approved for 47 indications, or types of treatment (some were approved to treat multiples forms of cancer). Nearly 100,000 patients received CDF-approved cancer treatments from 2010 to 2016. The researchers found that out of the 47 CDF-approved indications, 18 (38 percent) were deemed significantly beneficial toward overall survival. These drugs extended patients’ lives by an average of 3.1 months, but it ranged based on the patient from 1.4 months to 15.7 months. Twenty-six of the drugs were previously rejected by NICE for being not cost-effective enough to gain approval. In terms of clinical benefit, only 23 (48 percent) of the 47 drug indications met criteria from the American Society of Clinical Oncology, and nine (18 percent) met criteria from the European Society for Medical Oncology. The report goes as far as to say that some patients may have actually “suffered unnecessarily” from toxic side effects of the drugs they were taking. “We conclude the CDF has not delivered meaningful value to patients or society. There is no empirical evidence to support a ‘drug only’ ring fenced cancer fund relative to concomitant investments in other cancer domains such as surgery and radiotherapy, or other noncancer medicines,” stated the authors. In 2016, after years of exceeding budgets, the CDF underwent a three-month consultation. The Fund conducted its own assessment of trial evidence of the drugs it was paying for and removed more than half of the indications due to insufficient evidence of clinical benefit. Eighteen of the drugs were removed based on evidence that already existed when the fund originated, compounding the authors’ beliefs that money and resources were misused. The CDF was briefly shut down in March 2016 after being considered financially unsustainable. It was reorganized and opened again later in 2016. Now, the CDF is a managed access fund through the NHS and NICE. The CDF now supports the collection of evidence on the performance of promising new drugs. To ensure patients’ still receive swift access to potentially life-saving treatments, the NICE appraisal process now begins much earlier. In an accompanying editorial, Kapil Dhingra, associate editor of Annals of Oncology, noted the controversy of the CDF from its initiation, saying critics argued that “politics and heightened emotions” played a significant role in the decision-making surrounding CDF-reimbursement, instead of scientific data. Dhingra also addresses one key limitation of the study authors’ analysis – the real-world outcome data from patients who received CDF-approved drugs was lacking (through no fault of the study authors, Dhingra notes). He continues by saying the data should have been routinely collected starting in April 2012, but the authors had to rely on other published data – drawing attention to what critics consider the failed execution of the program.


News Article | April 26, 2017
Site: www.eurekalert.org

Sophia Antipolis April 26,2017. The impact of overtraining on the heart is set to be discussed at Europe's leading cardiovascular magnetic resonance meeting, to be held 25 to 27 May in Prague, Czech Republic, at the Clarion Congress Hotel Prague (CCHP). EuroCMR is the largest and most important cardiovascular magnetic resonance (CMR) event in Europe. It is the annual CMR conference of the European Association of Cardiovascular Imaging (EACVI), a registered branch of the European Society of Cardiology (ESC). The scientific programme is available here "Journalists can get the latest research findings on how athletes adapt to exercise and whether it's good or bad for them," said Professor James Moon, programme chair of EuroCMR. "There is a controversial suggestion that overtraining, especially if you're over 40, is not necessarily good for your heart." He continued: "We will also hear from Pierre Croisille from Jean Monnet University, Saint-Étienne, France, who scanned ultramarathon runners during the Tor des Géants during their 300 km race. The marathon is a model of training and adaptation - and the ultramarathon is more extreme -- it's almost a model of dying in intensive care as your body becomes really inflamed, so we have an opportunity to understand the heart at the limits." EuroCMR is Europe's leading clinical CMR meeting. More than 1 000 participants from over 60 countries are expected to attend the 2.5 day congress which is packed with state-of-the-art sessions led by international experts and new scientific research in the abstract programme. A future of universal genetic testing followed by magnetic resonance imaging (MRI) will be outlined in a keynote lecture by Dudley Pennell from the Royal Brompton Hospital in London, UK. Professor Moon said: "The genetics will tell you what diseases you might get - for example heart muscle disease - and the MRI will show where you are in the progression, whether or not you have to change things now or even apply invasive procedures, for example electrophysiology." Members of the press will learn about novel MRI scanners capable of reconstructing images using Microsoft Cloud. Juliano Fernandez from Brazil will reveal how a five minute scan he is testing in 23 countries could bring MRI to less developed countries. MRI has been contraindicated in patients with pacemakers and implantable cardioverter defibrillators (ICDs) but new research suggests that it may be safe and experts will present the current evidence. "We got this quite wrong and journalists can get the full story in a dedicated session," said Professor Moon. "We're moving towards a world where pacemakers are not a contraindication to MRI which is really important because everyone can get brain, spine or cancer scans they need." Adam Timmis from Barts Heart Centre and the National Institute for Health and Care Excellence (NICE), UK, will discuss the role of computed tomography (CT) scans for patients with chest pain, rather than MRI, echocardiography or electrocardiogram (ECG). Professor Moon said: "The UK is heading towards CT scanning first line for chest pain and the other modalities for refined diagnosis once coronary disease is present. This is a major change in direction. NICE is very credible, so the approach should be considered across Europe." Media representatives can get both sides of the story in a debate on when to operate in patients with valve disease. "Cardiologists replace a valve when it's very narrow but may not think about whether or not the heart muscle is coping," said Professor Moon. "It's a bit like performing a liver transplant in a heavy drinker without checking liver function. In the future we will measure how the heart is responding to the diseased valve using MRI and blood tests and then decide whether or not surgery is needed." 3D printing is a hot topic and journalists can have a close look at how imaging and printing the heart and vessels is helping plan operations for our sickest children and adults at Great Ormond Street Hospital, London and elsewhere. Graham Cole from Imperial College London will show where doctors got it wrong in imaging and how to avoid mistakes as researchers develop new treatments for the future. Professor Moon said: "MRI has transformed neurology and our understanding of the body. It's taken us longer in cardiology because the heart moves constantly. We have sorted those problems out and we are able to diagnose patients with cardiovascular disease earlier, tailor the treatment to the individual, and measure the effect of that treatment. Members of the press should register now for this exciting event."


News Article | February 16, 2017
Site: www.eurekalert.org

Pregnant women are almost twice as likely to quit smoking if they are supported from their first midwife appointment - and then are more likely to have heavier, healthier babies. Newcastle University researchers evaluated the "BabyClear" programme which follows the National Institute for Health and Care Excellence (NICE) guidance around smoking in pregnancy by screening all pregnant women for smoking using carbon monoxide monitoring. Any woman still smoking when she first saw a midwife, at around eight weeks into pregnancy, was given information about the risks to their unborn baby. She was then put in contact with agencies who could help her quit. Publishing today in Tobacco Control, the research team report that in the study of 40,000 mothers-to-be, the number of women helped to stop smoking almost doubled. Dr Ruth Bell, senior lecturer in the Institute of Health and Society at Newcastle University, who led the study, said: "This shows that if we help make it routine for midwives to ask about smoking and screen every mother-to-be for carbon monoxide, we can double the number of women who quit smoking in pregnancy and substantially increase the number of healthy babies." The team found the women who did not smoke in pregnancy, went on to have babies that were more than half-a-pound heavier (260 grams or 0.57lb) at full term, than those who continued to smoke. Even women who quit smoking during their pregnancy were shown to have heavier babies (by around 210 grams or 0.46lb) than those of mothers who smoked throughout pregnancy. This is an indicator of a healthier infant that is likely to need less medical help. The large study in NHS maternity units across the north east of England, included 10, 594 women who were smokers. Every woman was offered carbon monoxide (CO) monitoring and anyone with high carbon monoxide readings, indicating smoking, was routinely referred to Stop Smoking Services within 24 hours, where they received help to stop from a trained smoking cessation adviser. Dr Bell said: "Training midwives particularly on how to start a conversation about smoking, along with providing clear routes for women to get support to help stop smoking, ensured that national guidance was followed. This package proved to be highly effective in helping mothers to stop smoking, equivalent to nearly 100 extra quitters per year in a maternity unit delivering 3,000 babies." The study was funded by the NIHR School for Public Health Research (SPHR) and Fuse, the Centre for Translational Research in Public Health. The study examined the records of 37,726 births of single babies across the North East, including 10,594 to mothers who smoked during pregnancy. The authors report that the referral rate more than doubled (2.5 times higher) across all the trusts in the first three months after the introduction of the new approach. The introduction of the programmes was associated with a substantial increase in quitting during pregnancy, and quitting was associated with referral to stop smoking services. Further analysis of birthweight revealed that babies were significantly heavier if a mother quit smoking during pregnancy. Professor Eugene Milne, a co-author of the study and Director of Public Health at Newcastle City Council, said: "It is hard to overstate the impact that being smoke free can have on babies, mothers and families. "Reducing smoking reduces the risk of stillbirth, low birth weight, and of problems with health not only in childhood but into adult life and even old age. There is clear evidence that heavier babies have lower rates of heart disease in later life. "This new study provides important evidence that giving the right care to help pregnant mothers quit smoking is an effective and important intervention, and provides the information and help that mothers want. "We are working to ensure that all prospective mothers receive this standard of care and support in Newcastle and the North East." Economic analysis revealed that the additional cost of the intervention per delivery was £31. The work was possible as the North East has a regional approach to reducing smoking during pregnancy, embedding NICE guidance using the BabyClear approach developed by Improving Performance in Practice (iPiP). This was rolled out in the North East by Fresh, the North East's regional tobacco control programme, working with all of the North East's hospital foundation trusts and Stop Smoking Services. Smoking at the time of delivery rates have fallen in the North East since 2009/10 when 22.2% of women smoked at the time they gave birth, down to 16% in 2016. Ailsa Rutter, Director of Fresh, which supported the introduction of the approach across the region said: "These findings and the drastic decline in smoking in pregnancy in the North East by around a third since 2009 shows the vital role the NHS can play in reducing harm from tobacco. But it is vital this work continues. "There is a lack of awareness around just how smoking harms unborn babies and midwives played an important role in communicating this. Women overwhelmingly supported this approach, even if some initially found the facts shocking. "There has also been demand for this approach to be rolled out nationally by leads from the national Smoking in Pregnancy Challenge Group, a coalition working to reduce the harm caused by tobacco." Professor Linda Bauld, Co-Chair of the Smoking in Pregnancy Challenge Group and Professor of Health Policy at the University of Stirling said: "The North East of England has taken a lead in implementing recommendations from NICE and the Smoking in Pregnancy Challenge group, and progress achieved is impressive. "These results show the vital role health professionals can play when they raise the issue of smoking. These changes have undoubtedly saved lives and have implications that go beyond pregnancy for the role front line NHS professionals can play." Dr Bell adds: "Our analysis shows that by improving the links between midwives and smoking cessation services we can really help mothers give their babies the best start in life." REFERENCE: Evaluation of a complex healthcare intervention to increase smoking cessation in pregnant women: interrupted time series analysis with economic evaluation. Ruth Bell et al. Tobacco Control. Doi: 10.1136/tobaccocontrol-2016-053476 Melanie Snowdon, 40, from South Shields, welcomed her fifth child, Faith, to the world in March. When she found out she was expecting she sought support from her local stop smoking service to quit tobacco for the good of her unborn child. She's continued to be smoke free following the birth and is confident that she'll remain that way in the future. She said: "I was about 17 when I started smoking. In those days everybody smoked, we knew it was bad but you don't think about that when you're a teenager. On average I smoked about 20 - 30 a day and it wasn't until I was pregnant with my fifth child that I stopped. "I smoked through my first four pregnancies and there were no issues, I had four healthy babies. There was a big gap in between my first four and my youngest. "Not long after I married my husband, we fell pregnant again. I decided that I needed to quit smoking as my husband doesn't smoke and doesn't like it. "The thing that really hit home for me was when the midwife at hospital showed me how much carbon monoxide was in my breath and explained how smoking starves the baby of oxygen. "I was referred to my local stop smoking service and, at first, I was very sceptical. I used patches, sprays and an ecig for a little bit too and I managed to come off the cigarettes completely after seven weeks. "I couldn't quite believe the difference in weight, my daughter was 9lbs 12oz whereas all my other children were much lighter. I never believed that smokers had smaller babies. "I wasn't sure how I would do after my daughter was born but I'm still off the cigarettes and I can't see myself going back. I still carry a spray in my bag just in case but the thought and the smell of smoking really puts me off. "My husband has said he is really proud of me because he thought once the baby was born I would have started again. "I would encourage other mums to give it a try - it doesn't cost anything. I smoked for so many years and would never have thought I would be able to stop but I did."

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