The U.S. Food and Drug Administration has granted Priority Review designation to Genentech's supplemental Biologics License Application for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), a rare neurological condition.
The FDA accepted the filing based on results from the Phase III METEOROID study, which met its primary endpoint of time from randomization to first MOGAD relapse during the double-blind treatment period. Enspryng reduced the risk of a new relapse by 68% compared to placebo (p=0.0025), and 87% of treated patients remained relapse-free at 48 weeks versus 67% on placebo.
Improvements were also observed across secondary measures, including annualized relapse rate, MRI lesion activity, and rescue therapy use. The safety profile was described as consistent with data from more than a decade of clinical trial and post-approval experience with Enspryng in neuromyelitis optica spectrum disorder.
MOGAD is estimated to affect between 0.51 and 3.42 people per 100,000 worldwide. There are currently no approved treatments specifically for the disease.
Genentech, a member of the Roche Group, already markets Enspryng in approximately 90 countries for neuromyelitis optica spectrum disorder. The drug also holds FDA Priority Review status for thyroid eye disease, granted in June.
The European Medicines Agency has validated the application for Enspryng for MOGAD in Europe. The Phase III METEOROID study results were presented in April 2026 at the American Academy of Neurology Annual Meeting.
The FDA's expected decision date for the MOGAD indication is January 10, 2027. The EMA is expected to rule in the third quarter of 2027.
