FDA approves Alexion's Soliris for adult NMOSD patients
The U.S. Food and Drug Administration approved Soliris injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder, or NMOSD, in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord, the FDA noted. The FDA granted the approval of Soliris to Alexion Pharmaceuticals. Soliris was first approved by the FDA in 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, and for the treatment of adults with Myasthenia Gravis who are anti-acetylcholine receptor antibody positive.