Roche: FDA grants Priority Review for Enspryng in MOGAD

Regulatory update

The U.S. FDA has granted Priority Review to a supplemental Biologics License Application for Enspryng (satralizumab) in myelin oligodendrocyte glycoprotein antibody‑associated disease (MOGAD). The FDA’s decision is expected by 10 January 2027. The EMA has validated Roche’s MOGAD application, with a European Commission decision expected in the third quarter of 2027.

Key clinical data

The sBLA acceptance is based on the Phase III METEOROID trial presented at AAN 2026, which met its primary endpoint of time to first MOGAD relapse during the double‑blind period. Enspryng reduced the risk of a new relapse by 68% versus placebo (p=0.0025); 87% of treated patients were relapse‑free at 48 weeks versus 67% on placebo. The drug also showed significant improvements in annualised relapse rate, MRI lesion activity and use of rescue therapy.

Safety and prior experience

The METEOROID safety profile was reported as consistent with more than a decade of Enspryng clinical trial and post‑approval experience in neuromyelitis optica spectrum disorder (NMOSD). Enspryng is an IL‑6 receptor‑targeting humanised monoclonal antibody (satralizumab) with existing approvals for NMOSD in multiple countries and orphan designations for NMOSD and MOGAD.

Disease context

MOGAD is a rare autoimmune CNS disease causing unpredictable attacks on the optic nerves, brain and spinal cord that can lead to vision loss, weakness and lasting neurological disability; there are currently no approved treatments specifically for MOGAD.