U.S. FDA Grants Priority Review for Roche's Enspryng for MOGAD, a Rare Autoimmune Disease

The U.S. Food and Drug Administration (FDA) has granted Priority Review to Roche's supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD, a rare central nervous system autoimmune disease with no currently approved treatments. The decision is based on positive Phase III METEOROID study results, which showed Enspryng significantly reduced relapse risk.