FDA to review supplemental biologics license application for Enspryng

The FDA granted priority review to Roche's supplemental biologics license application for Enspryng, targeting myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), a rare autoimmune disorder. The FDA decision is expected by January 10, 2027, based on positive Phase 3 METEOROID trial results showing reduced relapse risk and improved clinical outcomes.

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