Roche announced that the FDA has accepted its supplemental biologics license application seeking approval of Enspryng, also known as satralizumab, for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease, or MOGAD, and granted the application a priority review with a decision expected on Jan. 10, 2027. If approved, Enspryng would become the first and only disease-modifying therapy for MOGAD, a rare autoimmune disease of the central nervous system that can cause unpredictable attacks affecting the optic nerves, spinal cord or brain and for which there are currently no approved treatments. The FDA's acceptance was based on positive data from the phase III METEOROID study, which met its primary endpoint, showing that treatment with Enspryng reduced the risk of a new MOGAD relapse by 68% compared with placebo, and that at 48 weeks 87% of patients treated with Enspryng remained relapse-free compared with 67% in the placebo arm. Separately, the European Medicines Agency has validated Roche's application for Enspryng in MOGAD, with a decision from the European Commission expected in the third quarter of 2027. Enspryng is currently approved in several countries for the treatment of neuromyelitis optica spectrum disorder, including the European Union and the United States, and Roche is also evaluating it in additional neurological autoimmune and inflammatory disorders, with the FDA having accepted and granted priority review in June 2026 to a separate sBLA seeking label expansion for thyroid eye disease and a final decision expected on Oct. 15, 2026.
Roche Holding AGFDA accepted and granted priority review to Roche's sBLA for Enspryng in MOGAD, with EMA validation, advancing a potential first-in-class approval.
