Roche's Enspryng granted FDA Priority Review for MOGAD
Key highlights
- The FDA accepted Roche’s application for Enspryng (satralizumab) for adult and adolescent MOGAD and granted Priority Review.
- The FDA is expected to issue a decision by 10 January 2027.
- The European Medicines Agency validated the Marketing Authorisation Application for Enspryng for adult MOGAD.
- A European Commission decision is expected in the third quarter of 2027.
US regulatory update
Roche’s application for Enspryng (satralizumab) to treat adult and adolescent patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) has been accepted by the U.S. Food and Drug Administration and granted Priority Review.
The FDA is expected to make its decision by 10 January 2027.
European procedure
The European Medicines Agency has validated the Marketing Authorisation Application for Enspryng for the treatment of adult patients with MOGAD.
The European Commission’s decision is expected in the third quarter of 2027.
Announcement
The update was published by Chugai reporting Roche’s regulatory filings and review timelines.
Source: Chugai Pharmaceutical