Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
10/09/2026
US FDA granted Priority Review to Roche’s Enspryng for MOGAD. (Ref)
Roche announced that the US FDA had granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab; anti- IL-6) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).
The filing acceptance was based on positive results from the Phase 3, METEOROID study, which showed that Enspryng provided consistent, clinically meaningful improvements for people living with MOGAD.
The FDA is expected to make a decision on approval in MOGAD by 10 January 2027.
The European Medicines Agency (EMA) had validated the application for Enspryng for MOGAD in Europe and Roche expects decision by the European Commission in the Q3 of 2027.
