Madrigal Secures EU Approval for First MASH Treatment
Wednesday, August 20, 2025
Madrigal Pharmaceuticals has received conditional marketing authorisation from the European Commission for Rezdiffra™ (resmetirom) to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stages F2–F3).
MASH is a progressive liver disease that has become one of the fastest-growing causes of liver transplantation in Europe. Patients with moderate to advanced fibrosis are at a significantly higher risk of liver-related mortality and progression to cirrhosis, highlighting the urgent need for treatment options. Madrigal estimates that around 370,000 patients with MASH and fibrosis are currently under specialist care across Europe.
Rezdiffra is a once-daily, oral therapy designed to act on key drivers of MASH. Approval was supported by results from the Phase 3 MAESTRO-NASH trial, which showed both fibrosis reduction and resolution of MASH, alongside improvements in liver stiffness, fat, enzymes, and blood lipids. At one year, most patients receiving Rezdiffra 100 mg experienced stabilisation or improvement in liver stiffness.
Rezdiffra is also approved in the United States under accelerated approval for the same patient group. It is not authorised for patients with cirrhosis, although further studies are under way to assess its benefits in this population.
This makes Rezdiffra the first approved therapy for MASH in the European Union.
The conditional authorisation follows a positive opinion from the Committee for Medicinal Products for Human Use in June 2025. The decision applies across all 27 EU Member States as well as Iceland, Liechtenstein and Norway.
Launches will be managed on a country-by-country basis, beginning in Germany later in 2025, subject to reimbursement procedures.
Source: madrigalpharma.com
