The FDA granted Priority Review for Roche’s Enspryng (satralizumab) to treat myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). MOGAD is a rare autoimmune disease affecting the central nervous system with no currently approved treatments. Enspryng would become the first and only disease-modifying therapy for the condition if approved.
Data from the Phase III METEOROID study supports the application. The drug reduced the risk of relapse by 68% compared to a placebo. Patients currently rely on off-label treatments such as high-dose steroids and immunosuppressants to manage attacks.
The FDA expects to issue a decision by January 10, 2027. The European Medicines Agency is also reviewing the drug for the same indication.