Madrigal Secures European Commission Approval for Rezdiffra™ to Treat MASH with Moderate to Advanced Liver Fibrosis
Wednesday, August 20, 2025
Madrigal Pharmaceuticals, Inc. has received conditional marketing authorisation from the European Commission (EC) for Rezdiffra™ (resmetirom), indicated for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. Rezdiffra is now the first therapy approved in the European Union for the treatment of MASH.
MASH is a progressive liver disease and a leading cause of liver-related mortality in Europe, with around 370,000 patients with moderate to advanced fibrosis currently under specialist care. The condition represents a growing challenge for healthcare systems and is the fastest-growing indication for liver transplantation in the region.
Rezdiffra is an oral, once-daily THR-β agonist that targets underlying causes of MASH. Approval was based on its favourable benefit-risk profile, including results from the Phase 3 MAESTRO-NASH trial, which demonstrated both fibrosis reduction and MASH resolution. The therapy also improved liver stiffness, liver fat, liver enzymes, atherogenic lipids, and health-related quality of life. At one year, 91% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of liver stiffness measured by vibrational-controlled transient elastography (VCTE).
The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued in June 2025. The authorisation is valid across all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway. The rollout of Rezdiffra will depend on national reimbursement procedures, with Germany expected to be the first country to launch the therapy in the fourth quarter of 2025.
Source: globenewswire.com
