Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), said on Thursday that the US Food and Drug Administration (FDA) has granted Priority Review to its supplemental application for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

The application is supported by Phase III METEOROID results showing that Enspryng reduced the risk of relapse by 68% versus placebo, while 87% of treated patients remained relapse-free at 48 weeks compared with 67% for placebo. The study also reported improvements in annualised relapse rate, MRI lesion activity and rescue therapy use.

If approved, Enspryng would become the first and only disease-modifying therapy for MOGAD, a rare autoimmune disease that can cause attacks affecting the optic nerves, brain and spinal cord.

The FDA is expected to decide on approval by 10 January 2027, while the European Medicines Agency has validated the European application, with a European Commission decision expected in the third quarter of 2027.

Genentech said Enspryng's safety profile in METEOROID was consistent with more than a decade of clinical trial and post-approval experience in neuromyelitis optica spectrum disorder (NMOSD).

The MOGAD application marks Enspryng's second FDA Priority Review, following a separate review granted in June 2026 for thyroid eye disease.