... See 17 PATIENT COUNSELING INFORMATION and the FDA-approved … In the Phase 3 REGAIN study and its ongoing open-label extension study, Soliris demonstrated treatment benefits for patients with anti-AchR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing. Eculizumab is an interesting target for biosimilar development, in that it treats rare diseases. : 125166 Approval Date: 03/16/2007. Aspergillus infections have occurred in immunocompromised and neutropenic patients. FDA Approves Soliris. June 27, 2019. First FDA-Approved Treatment in More Than 60 Years for Patients with gMG, a Chronic and Debilitating Neuromuscular Disorder NEW HAVEN, Conn.--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved Soliris ® (eculizumab) as a treatment for adult patients with generalized … 2009;8(5):475-490. The FDA based its approval of the extended indication for Soliris on comprehensive clinical data from the Phase 3, randomized, double-blind, placebo-controlled, multicenter REGAIN study (ECU-MG-301). Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. Eculizumab Receives FDA Approval for Neuromyelitis Optica Spectrum Disorder. Yale J Biol Med. ®. View the full release here: http://www.businesswire.com/news/home/20171023006539/en/, "Today's approval is a significant milestone for Alexion and, more importantly, for the subset of patients with anti-AchR antibody-positive gMG who continue to suffer from significant unresolved disease symptoms despite existing treatment options," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. On September 23, 2011 the U.S. Food and Drug Administration (FDA) approved Eculizumab (Soliris®) for the treatment of all pediatric and adult patients with atypical hemolytic uremic Publication date May 2017. http://www.ninds.nih.gov/disorders/myasthenia_gravis/detail_myasthenia_gravis.htm. Clinical © 2021 Alexion Pharmaceuticals, Inc. http://www.businesswire.com/news/home/20171023006539/en/, http://www.myasthenia.org/HealthProfessionals/ClinicalOverviewofMG.aspx, http://www.ninds.nih.gov/disorders/myasthenia_gravis/detail_myasthenia_gravis.htm. View source version on businesswire.com: http://www.businesswire.com/news/home/20171023006539/en/, Alexion Pharmaceuticals, Inc. Eculizumab was approved by the US Food and Drug Administration (FDA) in March 2007 for the treatment of PNH, Eculizumab has exclusivity rights until 2017, which protects it from competition until 2017. Under the Soliris REMS, prescribers must enroll in the program. Eculizumab had previously been FDA approved … Soliris … Huda R, Tüzün E, Christadoss P. Targeting complement system to treat myasthenia gravis. or InvestorsElena Ridloff, CFA, 475-230-3601 Alexion … The humanized monoclonal antibody eculizumab (Soliris ®) is a complement inhibitor indicated for use in anti-acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis (gMG) in the USA, refractory gMG in the EU, or gMG with symptoms that are difficult to control with high-dose IVIg therapy or PLEX in Japan.It is the first complement inhibitor to be approved … On March 16, 2007, eculizumab (Soliris; Alexion Pharmaceuticals, Inc. Cheshire, CT), a humanized monoclonal antibody that binds to the human C5 complement protein, received accelerated approval by the U.S. Food and Drug Administration for the treatment of patients with paroxysmal nocturnal hemoglobi … Visit MedWatch, or call 1-800-FDA-1088. Eculizumab is … Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Clinical "It is particularly significant that this approval of Soliris will provide a new option for those with gMG and especially for those who do not respond adequately to or cannot tolerate standard treatment options.". There are no available data on eculizumab use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage Animal studies using a mouse analogue of the eculizumab … Progress in Neurology and Psychiatry. Autoimmune myasthenia gravis: emerging clinical and biological heterogeneity. Company: Alexion Pharmaceuticals Application No. 2014;15(4):167-178. Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections. Arne Naeveke, PhD, 475-230-3774 Media Eculizumab … accelerated approval by the U.S. Food and Drug Administration for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. 2014; 25(4): 575-583. 2006; 116:2843-2354. 2009;5(3):209-214. J. Clin Neuromuscul Dis. Comply with the most current Centers for Disease Control (CDC)'s Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. Soliris ® (eculizumab) is the first and only medication approved by the FDA to treat adults with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Sathasivam S. Diagnosis and management of myasthenia gravis. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law. FDA Approves Alexion's Eculizumab for Neuromyelitis Optica Spectrum Disorder. Muscle Nerve. Suh J., Goldstein JM, Nowak RJ. Note: Documents in PDF format require the Adobe Acrobat Reader®. Alexion's new drug application in Japan for Soliris as a treatment for patients with anti-AchR antibody-positive refractory gMG has been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Silvestri N, Wolfe G. Treatment-refractory myasthenia gravis. Meriggioli MN, Sanders DB. Lancet Neurol. Rev. In patients with aHUS, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, and pyrexia. The FDA based its approval of the extended indication for Soliris on comprehensive clinical data from the Phase 3, randomized, double-blind, placebo-controlled, multicenter REGAIN study (ECU-MG-301). Meriggioli MN, Sanders DB. It clears the way for Amgen to produce and market its eculizumab biosimilar in the United States (pending Food and Drug Administration approval of ABP 959) on March 1, 2025. 2013;86(2):255-260. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenza type b (Hib). Alexion is the global leader in complement inhibition and has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Muscle Nerve. Executive Director, Product Communications Alexion Submits Application for Priority Review and Approval of … James F. Howard Jr., MD, Distinguished Professor of Neuromuscular Disease, professor of neurology, medicine and allied health, and chief of the … Soliris ® (eculizumab) is the FIRST AND ONLY FDA-approved complement inhibitor indicated for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). FDA Approves Soliris to Treat Generalized Myasthenia Gravis. Howard J. Myasthenia Gravis - A summary. National Institute of Neurological Disorders and Stroke. Soliris® (eculizumab) Concentrated solution for intravenous infusion . A randomized, double-blind, placebo-controlled phase II study of eculizumab in patients with refractory generalized myasthenia gravis. This news release contains forward-looking statements, including statements related to the potential medical benefits of Soliris® (eculizumab) for the treatment of generalized myasthenia gravis (gMG), and Alexion's future clinical, regulatory and commercial plans for Soliris for the treatment of myasthenia gravis. The drug must be dispensed with the FDA-approved patient Medication Guide that provides important information about the drug’s uses and risks. ", "This is a landmark day for the members of the U.S. myasthenia gravis community, who have not seen a therapy approved for generalized myasthenia gravis in more than 60 years," said Nancy Law, Chief Executive Officer of the Myasthenia Gravis Foundation of America (MGFA). The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients … It is approved for adult generalized myasthenia gravis patients who are anti-acetylcholine receptor (AchR) antibody-positive.FDA approval followed demonstrated benefits for these patients in a Phase 3 clinical trial (NCT01997229) called REGAIN. WASHINGTON -- The first treatment for neuromyelitis optica spectrum disorder (NMOSD), a relapsing autoimmune inflammatory condition, received FDA approval Thursday. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including for example, the risks and uncertainties of drug development, decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of eculizumab for the treatment of gMG, delays, interruptions or failures in the manufacture and supply of our products and our product candidates, failure to satisfactorily address matters raised by the FDA and other regulatory agencies, the possibility that results of clinical trials are not predictive of safety and efficacy results of our products in broader patient populations, the possibility that clinical trials of our product candidates could be delayed, the adequacy of our pharmacovigilance and drug safety reporting processes, the risk that third party payers (including governmental agencies) will not reimburse or continue to reimburse for the use of our products at acceptable rates or at all, the outcome of challenges and opposition proceedings to our intellectual property, assertion or potential assertion by third parties that the manufacture, use or sale of our products infringes their intellectual property, uncertainties surrounding legal proceedings, company investigations and government investigations, including investigations of Alexion by the SEC and DOJ, the risk that anticipated regulatory filings are delayed, the risk that estimates regarding the number of patients with gMG are inaccurate, and a variety of other risks set forth from time to time in Alexion's filings with the U.S. Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended June 30, 2017 and in our other filings with the U.S. Securities and Exchange Commission. Howard JF, Barohn RJ, Cutter GR et al. Relevant Topics. Jennifer Barrett, Associate Editor. It is not known if Soliris is safe and effective in children with NMOSD. (Eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (gMG) First FDA-Approved Treatment in More Than 60 Years for Patients with … Sanders DB, Wolfe, GI, Benatar M, et al. 2016;87(4):419-25. Instructions for Downloading Viewers and Players. 2011;37(2):136-143. Eculizumab will be available only through a risk evaluation and mitigation strategy program and "must be dispensed with the FDA-approved patient Medication Guide," the FDA said. FDA Approves Soliris to Treat Generalized Myasthenia Gravis. In the Soliris PREVENT study of patients with anti-AQP4 antibody-positive NMOSD, Soliris … Clinical Characteristics of Refractory Myasthenia Gravis Patients. Press Release: FDA Approves Soliris (Eculizumab) For The Treatment of Patients With Generalized Myasthenia Gravis (gMG) Summary: Alexion Pharmaceuticals announced Oct. 23, 2017, that the U.S. Food and Drug Administration (FDA) has approved eculizumab (brand name Soliris) as a treatment for adult patients with generalized … Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. Eculizumab (Soliris) is indicated for adult … Soliris is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). Initial U.S. Approval: 2007 . These patients represent approximately 5-10% of all patients with MG.1-6, This press release features multimedia. These patients are at an increased risk of disease exacerbations and crises that may require hospitalization and intensive care and may be life-threatening. Jennifer Barrett, Associate Editor. June 28, 2019. Soliris ® (eculizumab) is the first and only medication approved by the FDA to treat adults with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. The Center for Biosimilars Staff. Approval FDA Approves Ultomiris (ravulizumab-cwvz) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) Jun 19, 2018. Myasthenia Gravis Foundation of America. "I am pleased that the FDA recognized the comprehensive clinical data supporting the benefits of Soliris for patients with anti-AchR antibody-positive gMG," said Professor James F. Howard, M.D., Department of Neurology at the University of North Carolina, Chapel Hill, and lead investigator in the clinical development of this new indication. 1. 2008 Feb;37(2):141-9. Myasthenia gravis (MG) is a debilitating, chronic and progressive autoimmune neuromuscular disease that can occur at any age but most commonly begins for women before the age of 40 and men after the age of 60.7-10 It typically begins with weakness in the muscles that control the movements of the eyes and eyelids, and often progresses to the more severe and generalized form, known as gMG, with weakness of the head, neck, trunk, limb and respiratory muscles.10, While most patients with gMG can be managed with current therapies for MG, 10-15% of patients fail to respond adequately to or cannot tolerate multiple therapies for MG and continue to suffer profound muscle weakness, and severe disease symptoms that limit function.1,11,12 These patients can suffer from slurred speech, choking, impaired swallowing, double or blurred vision, disabling fatigue, immobility requiring assistance, shortness of breath, and episodes of respiratory failure. Approximately 73% of patients with NMOSD have AQP4 auto-antibodies, … orCatherine Hu, 475-230-3599 Vice President, Investor Relations In patients with gMG who are anti-AchR antibody-positive, the most frequently reported adverse reaction observed with Soliris treatment in the placebo-controlled clinical study (≥10%) was musculoskeletal pain. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. This website is intended only for residents of the United States. Neurology. Soliris has received Orphan Drug Designation (ODD) for the treatment of patients with MG in the U.S. and EU, and for the treatment of patients with refractory gMG in Japan.
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