Alexion confirms FDA approval of Soliris for treatment of NMOSD
Alexion Pharmaceuticals announced that the U.S. Food and Drug Administration approved Soliris for the treatment of neuromyelitis optica spectrum disorder, or NMOSD, in adult patients who are anti-aquaporin-4 antibody positive. Approximately three quarters of all patients with NMOSD test positive for anti-AQP4 auto-antibodies, the company said. The FDA approved Soliris following an expedited six-month priority review. NMOSD is a rare, severe autoimmune disease that attacks the central nervous system without warning. The European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare are reviewing Alexion's applications to add the treatment of NMOSD to the marketing authorizations for Soliris in the European Union and Japan, respectively, the company noted.