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FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.
FDA 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 agency announced in a June 27, 2019 press release. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. FDA had granted this application priority review, and the use for NMOSD received an orphan drug designation.
“This approval changes the landscape of therapy for patients with NMOSD,” said Billy Dunn, MD, director of the Division of Neurology Products in FDA’s Center for Drug Evaluation and Research, in the press release. “Having an approved therapy for this condition is the culmination of extensive work we have engaged in with drug companies to expedite the development and approval of safe and effective treatments for patients with NMOSD, and we remain committed to these efforts for other rare diseases.”
FDA granted the approval of Soliris to Alexion Pharmaceuticals. Soliris was first approved by FDA in March 2007. 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.
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 available only through a restricted program under a risk evaluation and mitigation strategy.