Roche (RHHBY) secured FDA Priority Review for a supplemental Biologics License Application to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) with Enspryng (satralizumab). The FDA is expected to decide by January 10, 2027.
MOGAD is a rare autoimmune disorder of the central nervous system with no approved treatments. If approved, Enspryng would be the first disease-modifying therapy available for the indication—a clear competitive moat in an orphan space.
The filing rests on Phase III METEOROID trial data. Enspryng reduced the risk of MOGAD relapses by 68 percent versus placebo (p=0.0025). Eighty-seven percent of Enspryng-treated patients remained relapse-free at 48 weeks, compared to 67 percent on placebo. The study also showed improvements in annualized relapse rate, MRI lesion activity, and reduced need for rescue therapy. Safety was consistent with over a decade of clinical experience in neuromyelitis optica spectrum disorder.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said MOGAD is unpredictable and debilitating, with each relapse risking permanent neurological damage. "Enspryng has the potential to significantly reduce serious attacks and decrease reliance on high-dose steroids and immunosuppressants," Garraway said.
This is Roche's second FDA Priority Review for Enspryng. The first was granted in June 2026 for thyroid eye disease, with an FDA decision anticipated by October 15, 2026. Enspryng holds orphan drug designation in the U.S. and European Union for neuromyelitis optica spectrum disorder and has investigational orphan drug designation in the U.S. for MOGAD.
The European Medicines Agency validated an Enspryng application for MOGAD in Europe. The European Commission is expected to decide in the third quarter of 2027.
