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News
The FDA has granted priority review to Roche's Enspryng (satralizumab) for myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), a rare autoimmune condition that can damage the optic nerves, brain, and spinal cord. Currently, no approved therapies exist for MOGAD. A decision is expected by January 10, 2027, which could make Enspryng the first-ever disease-modifying treatment for this condition.
The FDA has granted priority review to a supplemental biologics license application for Enspryng (satralizumab, Genentech/Roche) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) — a rare autoimmune disease that attacks the optic nerves, brain, and spinal cord, causing severe relapses, vision loss, and progressive neurological disability. Right now, there are zero approved treatment options for MOGAD, making this a potentially landmark development for patients.
The application is backed by data from the phase 3 METEOROID trial, which showed Enspryng significantly outperformed placebo in reducing relapses. The FDA is expected to issue its decision by January 10, 2027, and the European Commission is anticipated to weigh in by Q3 2027. Enspryng is already approved for neuromyelitis optica spectrum disorder (NMOSD), giving it an established safety track record.
By the Numbers:
Why it matters: MOGAD is a debilitating disease with no approved therapies. If the FDA greenlights Enspryng, it would become the first disease-modifying treatment for MOGAD — filling a critical gap for patients facing unpredictable, potentially disabling relapses.
