Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease. Both are infused therapies. Sales Director, Healthcare communications agency, London/ SE UK, Account Executive - Medical Communications - Cheshire. The US regulator approved Soliris (eculizumab) yesterday to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. The European Commission (EC) has approved Alexion Pharmaceuticals’ Soliris (eculizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), extending its current marketing authorisation. The FDA on Thursday approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Health care professionals should use caution when administering Soliris to patients with any other infection. About NMOSD Senior Account Director & Associate Director - Healthcare Ad... Programme Manager / Programme Director – Medical Education - Buc... Medical Writers (All levels) Editorial / Scientific Leads & ... Senior & Principal Medical Writers Medical Communications - ... Senior Account Director - Med Comms Agency. Account Manager - Creative Healthcare Communications - South Wes... SENIOR ACCOUNT MANAGER - MEDICAL COMMUNICATIONS. Eculizumab (Soliris®) is a humanized monoclonal antibody directed against the human complement component 5 (C5), inhibiting C5 enzymatic cleavage and thereby preventing the generation o f the Alexion’s Soliris obtains expanded approval for NMOSD in Japan 25 November 2019 (Last Updated November 25th, 2019 11:28) Alexion Pharmaceuticals has obtained approval from Japan’s Health, Labour and Welfare Ministry (MHLW) to expand the use of Soliris (eculizumab) to prevent relapse in anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD), including … The drug has already had its patent period extended in the US extended until 2027, giving Alexion significantly longer to ramp up sales of its successor treatment, Ultomiris, which gained FDA approval in December in PNH.Approval in NMOSD is expected later this year in Europe and in 2020 in Japan. The effectiveness of Soliris for the treatment of NMOSD was demonstrated in a clinical study of 143 patients with NMOSD who had antibodies against AQP4 (anti-AQP4 positive) who were randomized to receive either Soliris treatment or placebo. It is not known if Soliris is safe and effective in children with NMOSD. 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. Estimates vary, but NMOSD is thought to affect around 4,000 to 8,000 patients in the US. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). “Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients’ lives,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. SOLIRIS was approved for the treatment of NMOSD in adult patients who are anti-AQP4 antibody-positive by the U.S. Food and Drug Administration (FDA) in June 2019 and by the European Commission (EC) in August 2019. The FDA granted the approval of Soliris to Alexion Pharmaceuticals. Soliris was first given the FDA nod in March 2007 for paroxysmal nocturnal hemoglobinuria. The drug is approved to reduce destruction of red blood cells in adults with a rare blood disease called paroxysmal nocturnal hemoglobinuria, for the treatment of adults and children with a rare disease that causes abnormal blood clots to form in small blood vessels in the kidneys (atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy), and for the treatment of adults with Myasthenia Gravis who are anti-acetylcholine receptor antibody positive. First, the European Commission approved brand-name eculizumab (Soliris) for the treatment of adults with NMOSD who are anti-aquaporin-4 (AQP4) antibody positive. Silver Spring, MD – The U.S. Food and Drug Administration yesterday approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. The drug is now approved for neuromyelitis optica spectrum disorder (NMOSD) in adult patients, who are anti-aquaporin-4 (AQP4) antibody positive. A new approval in NMOSD will help Alexion's Soliris angle for $1 billion in sales by 2028, but getting first-line patients on board could be an issue. SOLIRIS received Orphan Drug Designation (ODD) for the treatment of NMOSD in the U.S., EU and Japan. var arr2 = [ 'Alexion', 'Soliris', 'Rare diseases' ]; Roche’s neuromyelitis optica spectrum disorder (NMOSD) drug Enspryng has scored US Food and Drug Administration (FDA) approval, setting up a market clash with Alexion’s Soliris. The FDA granted this application Priority Review. Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Soliris is a complement inhibitor indicated for: Before you can receive SOLIRIS, your doctor must enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal … The approval, which is the first of its kind, followed a 6-month priority review based on data from the PREVENT trial, which demonstrated safety and efficacy … 2. The drug maker, Alexion Pharmaceuticals, received FDA approval for the same indication in June. Before sharing sensitive information, make sure you're on a federal government site. Most attacks occur in clusters, days to months to years apart, followed by partial recovery during periods of remission. Binding of the anti-AQP4 antibody appears to activate other components of the immune system, causing inflammation and damage to the central nervous system. A supplemental New Drug Application is currently under review by regulatory authorities in Japan. In the NMOSD clinical trial, no cases of meningococcal infection were observed. With the approval of Soliris, there is now for the first time an FDA-approved treatment available to NMOSD patients to help reduce the risk of relapse.” The approval was built on data from the Phase III PREVENT trial. About Soliris Soliris ® (eculizumab) is approved by the FDA. The FDA approved the new indication on June 27, 2019. Home Working Medical Copy Writer & Senior Medical Copy Write... Editor & Senior Editor - Medical Communications - Home Based. The .gov means it’s official.Federal government websites often end in .gov or .mil. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Consequently, there is an unmet need for this orphan condition. FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. “This approval changes the landscape of therapy for patients with NMOSD. According to the National Institutes of Health, women are more often affected by NMOSD than men and African Americans are at greater risk of the disease than Caucasians. In June 2019, the FDA approved Soliris (eculizumab, Alexion Pharmaceuticals), the first therapy for the treatment of anti-aquaporin-4 (AQP4) auto­antibody-positive NMOSD. Soliris also reduced the need for hospitalizations and the need for treatment of acute attacks with corticosteroids and plasma exchange. Despite the recent Soliris and Uplizna approvals, about 40% of patients with NMOSD remain untreated. In patients with NMOSD, the body's immune system mistakenly attacks healthy cells and proteins in the body, most often in the optic nerves and spinal cord. Article by Patients should be monitored for early signs of meningococcal infections and evaluated immediately if infection is suspected. The site is secure. APPROVAL & LABELING We have completed our review of this application, as amended. for (counter=0; counter' + arr2[counter] + '
'); OPEN Health is a family of expert practices, working in partnership to drive positive change in healthcare communications & market... Communiqué Awards 2015: Winners in pictures, UK introduces Rare Diseases Framework to improve the lives of people with rare diseases, The five-step, rare disease-ready checklist, NICE backs first ‘ultra-orphan’ drug Soliris, Alexion's Soliris gets US approval for myasthenia gravis, Pharma Market Research Report - Predictions for 2016, Patient Partnerships: Challenges and Opportunities for Pharma, Learning about Rare Genetic Disorders on Undiagnosed Children’s Day. Anna Smith. This Prior Approval sBLA provides for the use of Soliris for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti­ aquaporin-4 (AQP4) antibody positive and for proposed modifications to the approved REMS. “This approval changes the landscape of therapy for patients with NMOSD. Soliris is the first and only approved … Alexion has gained a new FDA approved used for its rare disease blockbuster Soliris. European Commission Approves SOLIRIS® (eculizumab) For the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD) - SOLIRIS®(eculizumab) is the first and only approved medication for NMOSD in Europe-. Unlike Enspryng and Soliris, Uplizna showed an impact on the disability endpoint in pivotal testing. Soliris has a boxed warning to alert health care professionals and patients that life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris, and that such infections may become rapidly life-threatening or fatal if not recognized and treated early. Soliris is indicated in adults for the treatment of: Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). FDA Approved: Yes (First approved March 16, 2007) Brand name: Soliris Generic name: eculizumab Dosage form: Injection Company: Alexion Pharmaceuticals, Inc. Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials and ensure patients are vaccinated with meningococcal vaccine(s). 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 who are anti-aquaporin-4 (AQP4) antibody positive. WASHINGTON -- The first treatment for neuromyelitis optica spectrum disorder (NMOSD), a relapsing autoimmune inflammatory condition, received FDA approval Thursday. Approved: June 27, 2019. Compared to treatment with placebo, the study showed that treatment with Soliris reduced the number of NMOSD relapses by 94 percent over the 48-week course of the trial.
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