U.S. FDA Grants Priority Review for Roche's Enspryng for MOGAD

The U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). This regulatory action is based on positive results from the Phase III METEOROID study, which demonstrated clinically meaningful improvements for people living with MOGAD, an autoimmune disease currently without approved treatments.