FDA Grants Priority Review to Roche's Enspryng (Satralizumab) Supplemental BLA for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD); January 10, 2027 PDUFA Date
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced Thursday September 10, 2026 that the FDA granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab, a humanized anti-interleukin-6 receptor monoclonal antibody using recycling-antibody technology for extended IL-6 receptor blockade) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). MOGAD is a rare inflammatory central nervous system disorder attacking optic nerves, brain, and spinal cord with estimated prevalence of 0.51 to 3.42 per 100,000 people. It has no FDA-approved disease-modifying treatments. The Phase 3 METEOROID trial met its primary endpoint of time to first relapse during double-blind treatment with a 68% reduction in relapse risk versus placebo (p=0.0025) and secondary endpoints including 87% of Enspryng-treated patients relapse-free at 48 weeks (versus 67% on placebo), 66% lower annualized relapse rate, 79% fewer active MRI lesions, and 73% reduced rescue-therapy use. The FDA action date is January 10, 2027. Enspryng is currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD).