Genentech: FDA grants Priority Review for Enspryng in MOGAD

Regulatory update

The U.S. FDA has granted Priority Review to the supplemental Biologics License Application for Enspryng (satralizumab) in myelin oligodendrocyte glycoprotein antibody‑associated disease (MOGAD), with a target decision date of January 10, 2027. This is the second Priority Review for Enspryng after one granted for thyroid eye disease in June 2026. The European Medicines Agency has validated the MOGAD application and a European Commission decision is expected in the third quarter of 2027. Enspryng holds orphan drug designation in the U.S. and EU for NMOSD and MOGAD.

Clinical evidence

The Phase III METEOROID trial, a randomized, double‑blind, placebo‑controlled study in patients aged 12 and older, met its primary endpoint of time to first adjudicated MOGAD relapse. Enspryng reduced the risk of a new relapse by 68% versus placebo (p=0.0025); 87% of Enspryng‑treated patients were relapse‑free at 48 weeks compared with 67% in the placebo arm. Secondary endpoints showed reductions in annualized relapse rate, MRI lesion activity and rescue therapy use. The double‑blind period was event‑driven and ended after 28 adjudicated relapses; dosing was weight‑based subcutaneous injections at 0, 2 and 4 weeks, then every 4 weeks. Reported safety was consistent with over a decade of clinical trial and post‑approval experience in NMOSD.

Disease context

MOGAD is a rare autoimmune disorder of the central nervous system that commonly affects the optic nerves and can also involve the brain and spinal cord, producing severe, potentially disabling relapses. Prevalence is estimated at 0.51–3.42 per 100,000 people. There are currently no approved treatments for MOGAD, and relapses can cause accumulating, permanent neurological damage.