var arr2 = [ 'Alexion', 'Soliris', 'Rare diseases' ]; Before sharing sensitive information, make sure you're on a federal government site. Soliris also received FDA approval for the treatment of aHUS, gMG, and NMOSD. Sales Director, Healthcare communications agency, London/ SE UK, Account Executive - Medical Communications - Cheshire. 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. In clinical trials, Soliris reduced NMOSD relapses significantly, also reducing the need for hospitalizations. 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 is the first and only approved … About NMOSD 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). Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. "We are thrilled to have partnered with industry to catalyze research and development of targeted therapies to treat NMOSD. It is not known if Soliris is safe and effective in children with NMOSD. 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. var arr = [ 'alexion', 'soliris', 'rare_diseases' ]; APPROVAL & LABELING We have completed our review of this application, as amended. 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. Soliris is indicated for intravenous use (300 mg/30 mL injection) in patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody-positive.. Benefit: Soliris will impact the medical benefit as administration is an intravenous medication. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system, National Institute of Neurological Disorders and Stroke: Neuromyelitis Optica Information Page, FDA approved drugs: Questions and Answers. 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 … FDA Approved: Yes (First approved March 16, 2007) Brand name: Soliris Generic name: eculizumab Dosage form: Injection Company: Alexion Pharmaceuticals, Inc. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. The approval was granted under orphan drug designation, which will help extend the drug’s market exclusivity period. 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 U.S. Food and Drug Administration (FDA) approved SOLIRIS for the treatment of NMOSD in adult patients who are AQP4 antibody-positive on June 27, 2019. NMOSD mainly affects the optic nerves and spinal cord. Patients were randomized to receive Soliris or placebo. Consequently, there is an unmet need for this orphan condition. 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. Approved: June 27, 2019. for (counter=0; counter