US FDA Grants Priority Review to Roche's Enspryng for MOGAD, an Autoimmune Disease with No Approved Treatments

The U.S. Food and Drug Administration (FDA) has granted Priority Review to Roche's supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). MOGAD is a rare autoimmune disease with no currently approved treatments. The decision is based on positive results from the Phase III METEOROID study, which demonstrated that Enspryng significantly reduced the risk of new relapses by 68% compared to placebo. The FDA is expected to make an approval decision by January 10, 2027.