WEDNESDAY, Aug. 19, 2020 (HealthDay News) -- The U.S. Food and Drug Administration has approved the third treatment for neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody-positive, the agency announced Monday.
Enspryng (satralizumab-mwge) is an injectable treatment option that is administered every four weeks by the patient or a caregiver after they receive training from a health care provider.
Approval of Enspryng was based on two 96-week clinical trials. In the first study of 95 adults with NMOSD, 64 were anti-AQP4 antibody-positive. Compared with placebo, Enspryng led to a 74 percent reduction in the number of NMOSD relapses in patients who were anti-AQP4 antibody-positive. In the second study of 76 patients, including 52 who were anti-AQP4 antibody-positive, the number of relapses among anti-AQP4 antibody-positive patients was reduced by 78 percent with Enspryng compared with placebo. In both trials, researchers found no evidence of a benefit with Enspryng in patients who were negative for the anti-AQP4 antibody.
A warning on the risk for infection, including serious and potentially fatal infections, is included in the prescribing information for Enspryng. The label also includes warnings for elevated liver enzymes, decreased neutrophil counts, and hypersensitivity reactions. The most commonly reported side effects include nasopharyngitis, headache, upper respiratory tract infection, inflammation of the lining of the stomach, rash, joint and extremity pain, fatigue, and nausea.
Approval was granted to Genentech.