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

The U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Roche's Enspryng (satralizumab). This designation is for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), a rare autoimmune condition for which there are currently no approved treatments. The FDA's decision is based on positive results from the Phase III METEOROID study, which demonstrated clinically meaningful improvements for individuals living with MOGAD.