FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord | FDA

FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord | FDA





FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

The U.S. Food and Drug Administration has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng is the third approved treatment for the disorder.

The prescribing information for Enspryng includes a warning for increased risk of infection, including serious and potentially fatal infections – such as potential reactivation of hepatitis B and tuberculosis. Other warnings and precautions for Enspryng include elevated liver enzymes, decreased neutrophil counts and hypersensitivity reactions. The most common side effects observed were the common cold (nasopharyngitis), headache, upper respiratory tract infection, inflammation of the lining of the stomach, rash, joint pain, extremity pain, fatigue and nausea. Vaccination with live-attenuated or live vaccines is not recommended during treatment and should be administered at least four weeks before starting Enspryng.