News Article | May 24, 2017
ZUG, Switzerland--(BUSINESS WIRE)--The European Commission (EC) has granted a standard marketing authorization for FAMPYRA (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS), Biogen (NASDAQ: BIIB) announced today. The approval is based on the results of the Phase 3 ENHANCE study, which confirm the clinically meaningful benefits and safety of FAMPYRA over the long term in people with both relapsing and progressive forms of MS. The ENHANCE study was conducted following the EC’s conditional marketing authorization for FAMPYRA in 2011. FAMPYRA can be used alone or with existing MS therapies, including immunomodulatory drugs. “ Approximately 80 percent of people with MS experience walking impairment, one of the most common issues with the disease. We frequently hear from people living with MS that these walking challenges affect their independence, restrict their ability to work and negatively impact their overall quality of life,” said Jeremy Hobart, Ph.D., consultant neurologist at Plymouth Hospitals NHS Trust and professor of Clinical Neurology and Health Measurement at the Plymouth University Peninsula Schools of Medicine and Dentistry. “ Results from the ENHANCE study provided additional evidence that FAMPYRA is an effective treatment for MS and echo what I and other clinicians have observed in treating people with MS: FAMPYRA provides a clinically significant improvement in walking ability as well as on broader aspects of quality of life.” ENHANCE Results Reaffirm Clinically Meaningful Benefits of FAMPYRA Biogen initiated ENHANCE, the third Phase 3 study for FAMPYRA, to evaluate the long-term safety and efficacy of the therapy in walking improvement in people with MS who have walking disabilities (as measured by Expanded Disability Status Scores [EDSS] of 4.0 – 7.0). ENHANCE, the largest and longest randomized trial of FAMPYRA, included patients with primary-progressive, secondary-progressive, progressive-relapsing and relapsing-remitting MS. Results, first reported in 2016, show that over 24 weeks: “ FAMPYRA is a valued medication among MS patients and physicians that addresses one of the most prevalent and disruptive symptoms of the disease. For the past several years, Biogen has been focused on ensuring that FAMPYRA is available to MS patients in Europe who experience walking disability,” said Ferenc Tracik, M.D., vice president, EU+ Medical Affairs. “ The approval of the standard marketing authorization for FAMPYRA is validation of the substantial difference this therapy has made on the lives of people with MS, and speaks to our deep, long-standing commitment to the MS community.” About FAMPYRA® FAMPYRA® (prolonged-release fampridine tablets) is a treatment indicated to improve walking in adult patients with MS. Biogen has a license from Acorda Therapeutics, Inc. to develop and commercialise FAMPYRA in all markets outside the United States. FAMPYRA is the first treatment to both address the unmet medical need of walking improvement in adults living with MS, and demonstrate clinical efficacy in adults with MS. FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs. In clinical trials, patients responding to FAMPYRA had an average increase in walking speed of 25 percent and FAMPYRA was shown to provide a clinically meaningful improvement in walking. The highest incidence of adverse reactions identified from placebo-controlled trials in MS patients with FAMPYRA, given at the recommended dose, was urinary tract infection (in approximately 12% of patients), although infection was often not proven by culture. Adverse drug reactions identified were mainly divided between neurological disorders (such as insomnia, balance disorder, dizziness, paraesthesia, headache, anxiety and tremor) and gastrointestinal disorders (including nausea, vomiting, dyspepsia and constipation). Other common adverse drug reactions reported were asthenia, back pain, pharyngolaryngeal pain and dyspnea. In post-marketing experience, there have been reports of seizures, hypersensitivity reactions (including anaphylaxis) and exacerbations of trigeminal neuralgia (TN) in patients with a history of TN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. For further information on FAMPYRA in your country please click here. U.S. residents: For information, please visit Acorda Therapeutics. About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube. Safe Harbor This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits, safety and efficacy of FAMPYRA and the results of certain real-world data. These forward-looking statements may be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements or the scientific data presented. Drug development and commercialization involve a high degree of risk. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation: unexpected concerns that may arise from additional data or analysis; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of Biogen’s drug candidates or expansion of product labeling; or Biogen may encounter other unexpected hurdles which may be impacted by, among other things, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect intellectual property and other proprietary rights, product liability claims or third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Hayes G.E.,Plymouth Hospitals NHS Trust |
Denning D.W.,University of Manchester
Current Opinion in Pulmonary Medicine | Year: 2013
Purpose of review: This review highlights key recent advances in fungal respiratory infections, encompassing developments in epidemiology, diagnostics and management, focussing on Aspergillus, Pneumocystis and Cryptococcus as key pathogens. Recent findings: Chronic pulmonary aspergillosis complicates existing lung diseases, particularly those associated with cavities or bullae, with a high global disease burden (prevalence estimate >1.1 million following tuberculosis) and significant under diagnosis (using Aspergillus IgG antibody). Several new treatment studies have been published (using caspofungin and voriconazole). Pneumocystis jirovecii demonstrates airborne transmission between infected and noninfected individuals necessitating isolation, and possibly identifying colonized patients. Early detection of serum cryptococcal antigenaemia in HIV may prevent development of meningitis, reducing morbidity and mortality, and routine testing of serum in communityacquired pneumonia cases in high endemicity areas may be helpful. Respiratory Aspergillus antigen and PCR testing is more sensitive than culture or serum testing. A new lateral flow antigen testing device may provide rapid bedside diagnosis of aspergillosis. Azole resistance to Aspergillus fumigatus is increasing across Europe. Summary: The field of fungal respiratory infection continues to evolve and develop, with many recent key advances. Patients, and possibly colonized patients, with Pneumocystis require isolation in hospitals and preferably segregation in outpatients. Challenges remain in almost all areas, with further work needed to identify the true burden of Aspergillus disease and address the increasing problem of azole resistance. Copyright © 2013 Lippincott Williams & Wilkins.
Akoh J.A.,Plymouth Hospitals NHS Trust
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia | Year: 2015
Transplant nephrectomy (TN) is associated with significant morbidity and mortality and influences the outcome of subsequent renal transplantation. The aim of this study was to identify the reasons for TN in a single transplant center in the United Kingdom and to determine the complication rate, effect on relisting and re-transplantation. We studied all the TNs in our center from January 2000 to December 2011. Detailed information including cause of allograft failure and reason for TN were analyzed. Of 602 renal transplants performed at our center during the period of the study, 42 TNs were performed on 38 (6%) patients (24 men and 14 women). The median age of the patients at the time of transplantation who subsequently underwent TN was 56 years (range: 28-73 years) and 71% of the allografts were donated after circulatory death. The mean human leucocyte antigen mismatch for these patients was 2.3. The most commonly used immunosuppression was a combination of prednisolone, mycophenolate and tacrolimus, which was used in 50% of the patients. Twenty-five (60%) of the TNs in this series were for allografts failing during the first month of transplantation. The most common indication for the TN was graft thrombosis (50%), with an overall in-hospital mortality rate of 9.5% and a morbidity rate of 31%. Seven of 19 patients listed underwent successful re-transplantation. Although TN is associated with a risk of significant morbidity and mortality, it does not preclude from listing for re-transplantation. The difficulty of access to complete information about transplant failures and TN highlights the need for a national registry.
Akoh J.A.,Plymouth Hospitals NHS Trust
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia | Year: 2013
Previous reports regarding donation after cardiac death (DCD) have called for caution in extending the age of kidney donors beyond 60 years due to the risk of poor graft function. The aim of this study was to determine the impact of donor age on renal transplantation from DCD in one center. All DCD transplants from 2005 to 2009 were included in the study. Immunosuppression and recipient follow-up were as per unit protocol. Donor and recipient details were entered prospectively into a renal database and analyzed for graft outcome. Of the 147 renal transplants, 102 were from donors <60 years old and 45 were from donors ≥60 years old. The incidence of delayed graft function varied significantly according to donor-recipient age groups (P = 0.01). The mean glomerular filtration rate at 12 months was 50.3 mL/min for transplants from young donors compared with 39.3 mL/min for transplants from old donors (P = 0.001). The cumulative graft survival rates at 1 and 5 years were 88% and 79% for young donors, while for old donors these were 78% and 72%, respectively (P = 0.101). By transplanting kidneys from old DCD donors into elderly patients, their survival is improved compared with dialysis, and organs from younger donors are made available for younger recipients.
Akoh J.A.,Plymouth Hospitals NHS Trust
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia | Year: 2011
Patients with established renal failure, living in developing countries, face many obstacles including lack of access to transplantation centers, quality and safety issues, and exploittation associated with transplant tourism. This review aims to determine the state and outcome of renal transplantation performed in developing countries and to recommend some solutions. The lack of suitable legislation and infrastructure has prevented growth of deceased donor programs; so, living donors have continued to be the major source of transplantable kidneys. Transplant tourism and commercial kidney transplants are associated with a high incidence of surgical complications, acute rejection and invasive infection, which cause major morbidity and mortality. Developing transplant services worldwide has many benefits - improving the results of transplantation as they would be performed legally, increasing the donor pool, making transplant tourism unnecessary and granting various governments the moral courage to fight unacceptable practices. A private-public partnership underpinned by transparency, public audit and accountability is a prerequisite for effective transplant services in the developing world. Finally, lack of dialysis facilities coupled with better outcomes in patients spending <6 months on dialysis prior to transplantation favor pre-emptive transplantation in developing countries.
Sahu A.,Plymouth Hospitals NHS Trust
Hand surgery : an international journal devoted to hand and upper limb surgery and related research : journal of the Asia-Pacific Federation of Societies for Surgery of the Hand | Year: 2012
Little finger metacarpal fractures are the most common type of metacarpal fractures and the treatment is quite variable as it is a multifactorial entity comprised of subcapital, metacarpal shaft and base fractures. These fractures are common presentations in the fracture clinics and the general orthopaedic surgeons treat them until a complex case warrants specific decision making by a hand surgeon. The management of many of these fractures is still a matter of debate and differ widely in the various parts of the United Kingdom. The aim of this study was to investigate the current practice of little finger metacarpal fractures among upper limb surgeons in the UK. We conducted an online survey among 278 upper limb orthopaedic specialist surgeons throughout the UK. Our response rate was 58%. There are various factors which dictate the treatment as suggested by these respondent upper limb consultants. For example, for fifth metacarpal neck fractures, it was generally recognised that 43% of upper limb surgeons prefer neighbour strapping alone for non-operative management of little finger metacarpal fractures. For little finger metacarpal shaft fractures, 39.3% of surgeons suggested that they would contemplate intervention, i.e. manipulation under anaesthesia/surgery if beyond 30° of volar angulation is present. For little finger metacarpal neck fractures, 33.7% would only consider surgical intervention beyond 60° of volar angulation. 91.6% of upper limb specialists agreed that they would operate on little finger metacarpal base fractures only if it was a fracture dislocation, while 71.8% suggested that they would proceed to operate on even a pure dislocation. We have illustrated the various permutations and combinations of these fractures with the results of our survey in this article in detail. The vast majority of metacarpal bone fractures are stable and treated conservatively. The different types of injury patterns must be recognised by the orthopaedic surgeons and appropriate treatment then should be executed to serve the patient optimally in due course.
Akoh J.A.,Plymouth Hospitals NHS Trust
Current Infectious Disease Reports | Year: 2011
Infection is the most challenging and life-threatening complication of vascular access and causes significant morbidity, loss of access, and mortality. The aims of this review are to determine the magnitude of the infection problem, identify possible factors, and provide an update on the management of vascular access infections. Infections account for approximately 15% to 36% of all deaths in dialysis patients (the second leading cause after cardiovascular events) and for about 20% of admissions. Several studies demonstrate a hierarchy of infection risk from temporary catheter, tunnelled cuffed catheter, arteriovenous grafts, to arteriovenous fistula in decreasing order. Suspicion of infection must be followed by appropriate blood cultures, including possible simultaneous sampling from a peripheral vein and the access. The best way to treat vascular access infection is prevention, bearing in mind the idea "fistula first" and "lines last", with the appropriate use of arteriovenous grafts and newer devices sandwiched in between. © 2011 Springer Science+Business Media, LLC.
Rockett M.,Plymouth Hospitals NHS Trust
Current Opinion in Anaesthesiology | Year: 2014
Purpose of review: The incidence and disease course of complex regional pain syndrome (CRPS) has been unclear until recently. This was due to inconsistent diagnostic criteria used in previous studies and a lack of large-scale prospective datasets. Multiple mechanisms of CRPS have been suggested, and recent research has begun to explain how inflammation, the immune system and the autonomic nervous system may interact with aberrant central neuroplasticity to produce the clinical picture. This review summarizes progress in these fields. Recent findings: National registries of patients with CRPS have provided us with an invaluable insight into the epidemiology of the disorder. We now have a better understanding of the disease course and expected outcome. Widespread sensory abnormalities, not limited to the CRPS limb, have been found suggesting that systemic changes may occur. Parietal lobe dysfunction and problems with sensory-motor integration have also been revealed. Abnormalities in the immune system in CRPS have also been demonstrated. Summary: Recent findings: in diverse research fields suggest novel treatment options for CRPS: from targeting autoimmunity to correcting abnormal body image. Many of the advances in our understanding of CRPS have arisen from the development of collaborative research efforts, such as the TREND group in the Netherlands. Copyright © Lippincott Williams & Wilkins.
Freeman R.M.,Plymouth Hospitals NHS Trust
Maturitas | Year: 2010
The exact success rate from conventional as well as new surgical procedures for pelvic organ prolapse is unknown possibly due to the lack of standardisation of outcome measures. Usually objective measures, e.g. Pelvic Organ Prolapse Quantification (POPQ) assessment have been used as the primary outcome in most studies which show that procedures such as anterior repair have a poor outcome. However these outcomes correlate poorly with subjective assessment and re-operation rates are lower than the anatomical failure rate suggesting that conventional surgery might not have as poor an outcome as previously suggested. Nonetheless, new procedures have been introduced for which efficacy and safety data are required via well conducted randomised controlled trials. © 2009.
Plymouth Hospitals Nhs Trust | Date: 2012-05-14
An episiotomy scissors (2) for use in conducting an episiotomy on a subject is provided, the scissors comprising a pair of pivotably connected scissor members; (4a, 4b) each scissor member comprising a handle (6a, 6b) extending in a proximal direction from the pivot connection and a blade (8a, 8b) extending in a distal direction from the pivot connection; and a guide member (20) mounted to a scissor member and having a guide surface (22a, 22b) extending in a distal direction from the scissor member at an acute angle to the longitudinal axis of the blade of the scissor member.