FDA Grants Priority Review to Roche's Enspryng for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (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), a rare autoimmune disease of the central nervous system with no currently approved treatments. The decision is based on positive Phase III METEOROID study results.