Chugai Pharmaceutical Co.

Gotemba, Japan

Chugai Pharmaceutical Co.

Gotemba, Japan

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News Article | May 22, 2017
Site: www.businesswire.com

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010. “Today’s FDA decision means people living with giant cell arteritis will, for the first time, have an FDA-approved treatment option for this debilitating disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With no new treatments in more than 50 years, this approval could be transformational for people with GCA and for their physicians.” The approval is based on the positive outcome of the Phase III GiACTA study evaluating Actemra in patients with GCA. The results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks (56 percent in the Actemra weekly group and 53.1 percent in the Actemra bi-weekly group) compared to placebo combined with a 26-week steroid taper (14 percent) and placebo combined with a 52-week steroid taper (17.6 percent).1 GiACTA (NCT01791153) is a Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the first successful clinical trial conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The primary endpoint was evaluated at 52 weeks. GCA, also known as temporal arteritis (TA), affects an estimated 228,000 people over the age of 50 in the U.S., and the disease is two to three times more likely to affect women than men.2,3 GCA is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke.3 Treatment to date for people with GCA has been limited to high-dose steroids that play a role as an effective ‘emergency’ treatment option to prevent damage such as vision loss.3 Due to the variability of symptoms, complexity of the disease and disease complications, people with GCA are often seen by several physicians including rheumatologists, ophthalmologists and neurologists. Actemra is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. In addition, Actemra is also used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older. Actemra is not approved for subcutaneous use in people with PJIA or SJIA. It is not known if Actemra is safe and effective in children with PJIA or SJIA under two years of age or in children with conditions other than PJIA or SJIA. Actemra is intended for use under the guidance of a healthcare practitioner. Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections. Actemra can cause other serious side effects. These include: Patients should not receive Actemra if they are allergic to Actemra or if they have had a bad reaction to Actemra previously. Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away: Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register. Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835-2555. Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672). Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia. Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.


News Article | May 17, 2017
Site: www.prnewswire.com

How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new 164-page report you will receive 84 tables and 93 figures - all unavailable elsewhere. The 164-page report provides clear detailed insight into the global erythropoietin market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Revenue forecasts of global erythropoietin market, segmented by product type: - Epoetin Alfa - Epoetin Beta - Darbepoetin Alfa - Biosimilars - Others This section also discusses the leading drugs as well as SWOT analysis of each submarket. • Revenue forecasts of global erythropoietin market, segmented by application: - Anemia (Cancer and HIV Treatment) - Kidney Disorders (ESRD and Dialysis) - Others Forecast for each regional market is further segmented by product type, application and country: - US - Canada - UK - Germany - France - Spain - Italy - Rest of Europe - China - Japan - India - Rest of Asia-Pacific - Brazil - Mexico - Rest of Latin America - Saudi Arabia - South Africa - Rest of Middle East and Africa • Assessment of selected leading companies that hold major market shares in the erythropoietin market: - Amgen - Johnson & Johnson - Roche - Biocon - 3SBio - Pfizer - Kyowa Hakko Kirin Co Ltd - LG Life Sciences Limited - Intas Pharmaceuticals Ltd - Novartis AG Visiongain's study is intended for anyone requiring commercial analyses for the erythropoietin market. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 3SBio Inc. Accord Healthcare Limited Actavis Akebia Therapeutics Amgen Astellas Pharma Inc AstraZeneca Bio Sidus SA Biocon Ltd Casa Marzam Casa Saba Chugai Pharmaceutical Claes-Göran Östenson Corvidia Therapeutics DaVita Inc Dr. Reddy's Laboratories FibroGen First Shanghai Investments Limited Fresenius Medical Care North America (FMCNA) Galenica Germans Trias i Pujol Hospital GlaxoSmithKline H. Lundbeck A/S Hoffmann-La Roche Hospira Janssen Biotech Japan Chemical Research Pharmaceuticals Co., Ltd. Johnson & Johnson Kissei pharmaceuticals Kosin University Gospel Hospital Kyowa Hakko Kirin Co Ltd LG Life Sciences Limited NADRO NovaQuest Co-Investment Fund I, L.P. Novartis Institutes for BioMedical Research (NIBR) Novartis Pharmaceuticals NOXXON Pharma AG Pfizer Proveedora de Medicamentos RPG Life Sciences Sandoz Sirton Pharma Stada Stem Cell Therapeutics Corp. Teva Pharmaceutical Industries Ltd. UBI Pharma Inc. Vifor Pharma List of Organizations Mentioned in the Report Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) Centers of Disease Control and Preventions China's Ministry of Health (MOH) Committee for Medicinal Products for Human Use (CHMP) Department of Health & Family Welfare of Karnataka Deutsches Ärzteblatt EMA European Commission (EC) FDA Indian Council of Medical Research (ICMR) International Agency for Research on Cancer (IARC) Ministry of Health, Malaysia National Cancer Institute National Center for Biotechnology Information National Kidney Foundation UK Nephrology - Renal Association World Cancer Research Fund International World Health Organizations To see a report overview please email Sara Peerun on sara.peerun@visiongain.com


News Article | May 17, 2017
Site: www.prnewswire.co.uk

How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new 164-page report you will receive 84 tables and 93 figures - all unavailable elsewhere. The 164-page report provides clear detailed insight into the global erythropoietin market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Revenue forecasts of global erythropoietin market, segmented by product type: - Epoetin Alfa - Epoetin Beta - Darbepoetin Alfa - Biosimilars - Others This section also discusses the leading drugs as well as SWOT analysis of each submarket. • Revenue forecasts of global erythropoietin market, segmented by application: - Anemia (Cancer and HIV Treatment) - Kidney Disorders (ESRD and Dialysis) - Others Forecast for each regional market is further segmented by product type, application and country: - US - Canada - UK - Germany - France - Spain - Italy - Rest of Europe - China - Japan - India - Rest of Asia-Pacific - Brazil - Mexico - Rest of Latin America - Saudi Arabia - South Africa - Rest of Middle East and Africa • Assessment of selected leading companies that hold major market shares in the erythropoietin market: - Amgen - Johnson & Johnson - Roche - Biocon - 3SBio - Pfizer - Kyowa Hakko Kirin Co Ltd - LG Life Sciences Limited - Intas Pharmaceuticals Ltd - Novartis AG Visiongain's study is intended for anyone requiring commercial analyses for the erythropoietin market. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 3SBio Inc. Accord Healthcare Limited Actavis Akebia Therapeutics Amgen Astellas Pharma Inc AstraZeneca Bio Sidus SA Biocon Ltd Casa Marzam Casa Saba Chugai Pharmaceutical Claes-Göran Östenson Corvidia Therapeutics DaVita Inc Dr. Reddy's Laboratories FibroGen First Shanghai Investments Limited Fresenius Medical Care North America (FMCNA) Galenica Germans Trias i Pujol Hospital GlaxoSmithKline H. Lundbeck A/S Hoffmann-La Roche Hospira Janssen Biotech Japan Chemical Research Pharmaceuticals Co., Ltd. Johnson & Johnson Kissei pharmaceuticals Kosin University Gospel Hospital Kyowa Hakko Kirin Co Ltd LG Life Sciences Limited NADRO NovaQuest Co-Investment Fund I, L.P. Novartis Institutes for BioMedical Research (NIBR) Novartis Pharmaceuticals NOXXON Pharma AG Pfizer Proveedora de Medicamentos RPG Life Sciences Sandoz Sirton Pharma Stada Stem Cell Therapeutics Corp. Teva Pharmaceutical Industries Ltd. UBI Pharma Inc. Vifor Pharma List of Organizations Mentioned in the Report Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) Centers of Disease Control and Preventions China's Ministry of Health (MOH) Committee for Medicinal Products for Human Use (CHMP) Department of Health & Family Welfare of Karnataka Deutsches Ärzteblatt EMA European Commission (EC) FDA Indian Council of Medical Research (ICMR) International Agency for Research on Cancer (IARC) Ministry of Health, Malaysia National Cancer Institute National Center for Biotechnology Information National Kidney Foundation UK Nephrology - Renal Association World Cancer Research Fund International World Health Organizations To see a report overview please email Sara Peerun on sara.peerun@visiongain.com

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