US FDA Accepts Roche Supplemental Application for Central Nervous System Autoimmune Disease Drug

01:29 AM EDT, 09/10/2026 (MT Newswires) -- Roche (RO.SW) said Thursday that the US Food and Drug Administration accepted its supplemental biologics license application for Enspryng, satralizumab, for priority review for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease, or MOGAD. The acceptance follows positive results from the phase 3 Meteoroid study, where Enspryng reduced the risk of relapses in MOGAD patients by 68%. The regulator is expected to decide by Jan. 10, 2027. The FDA in June 2026 granted Enspryng's priority review for thyroid eye disease. The European Medicines Agency has also validated the application for Enspryng for MOGAD, with a European Commission decision expected in the third quarter of 2027.