Roche's Enspryng Receives FDA Priority Review for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

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 MOGAD, a rare autoimmune disease of the central nervous system with no currently approved treatments. The filing is based on positive Phase III METEOROID study results, which demonstrated that Enspryng significantly reduced the risk of relapses. An FDA decision is anticipated by January 10, 2027.