EMA — authorised 18 August 2025
- Application: EMEA/H/C/006220
- Marketing authorisation holder: Madrigal Pharmaceuticals EU Limited
- Local brand name: Rezdiffra
- Indication: Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
- Pathway: conditional
- Status: approved
The European Medicines Agency (EMA) approved Rezdiffra (MGL-3196) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. This approval was granted on 18 August 2025, under the conditional marketing authorisation pathway. Rezdiffra is indicated for use in conjunction with diet and exercise.