U.S. FDA Grants Priority Review for Genentech’s Enspryng for MOGAD, an Autoimmune Disease With No Approved Treatments

— If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease).
— Filing acceptance is based on the Phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68% .
— MOGAD is a rare disease of the central nervous system characterized by unpredictable attacks of the optic nerves, spinal cord or brain.

South San Francisco, CA — September 9, 2026 —

Genentech, a member of the Roche Group announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng^® (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The filing acceptance is based on positive results from the Phase III METEOROID study, which showed that Enspryng provided consistent, clinically meaningful improvements for people living with MOGAD. This marks the second FDA Priority Review for Enspryng, following the one granted for thyroid eye disease (TED) in June. The FDA is expected to make a decision on approval in MOGAD by January 10, 2027. 

Additionally, the European Medicines Agency (EMA) has validated the application for Enspryng for MOGAD in Europe. The decision by the European Commission is expected in the third quarter of 2027.

“MOGAD can be unpredictable and debilitating, with each relapse carrying the potential for lasting neurological damage, yet there are currently no approved treatments,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Enspryng has the potential to transform care for people living with MOGAD, significantly reducing serious attacks and decreasing the reliance on high-dose steroids and immunosuppressants.”

The METEOROID study, presented at the American Academy of Neurology (AAN) Annual Meeting in April 2026, met its primary endpoint of time from randomization to the first MOGAD relapse during the double-blind treatment period. Enspryng significantly reduced the risk of a new relapse by 68% compared to placebo (p=0.0025), with 87% of Enspryng-treated patients remaining relapse-free at 48 weeks compared to 67% in the placebo arm. Enspryng also provided significant improvements across key secondary measures, including annualized relapse rate, MRI lesion activity and rescue therapy use.  

The safety profile in the METEOROID study was consistent with data from more than a decade of Enspryng clinical trial and post-approval experience in neuromyelitis optica spectrum disorder (NMOSD).

MOGAD is a rare autoimmune disease where the immune system mistakenly attacks parts of the central nervous system. It can cause sudden attacks on the optic nerves, brain and spinal cord, which can lead to vision loss, confusion, muscle weakness and disability.

About the METEOROID study – CLICK here to continue reading