U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments

Basel, 10 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that 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). The filing acceptance is based on positive results from the Phase III METEOROID study, which showed that Enspryng provided consistent, clinically meaningful improvements for people living with MOGAD.1 This marks the second FDA Priority Review for Enspryng, following the one granted for thyroid eye disease (TED) in June 2026. The FDA is expected to make a decision on approval in MOGAD by 10 January 2027.