Madrigal’s Rezdiffra Approved in EU for MASH Treatment

Madrigal Pharmaceuticals, Inc. has received conditional marketing authorization from the European Commission (EC) for Rezdiffra (resmetirom), making it the first and only approved therapy in the European Union for adults with noncirrhotic MASH (metabolic dysfunction-associated steatohepatitis) with moderate to advanced liver fibrosis.

The approval represents a major milestone in the treatment of MASH, a progressive liver disease and the fastest-growing cause of liver transplants in Europe. Until now, no approved therapies were available for patients suffering from this condition.

“This approval of Rezdiffra marks a historic breakthrough for patients in Europe living with MASH,” said Bill Sibold, CEO of Madrigal. “The European labeling requires no biopsy for diagnosis and focuses on patients with F2-F3 fibrosis — a group with high unmet medical need and a significantly increased risk of liver-related mortality.”

Madrigal estimates that approximately 370,000 patients in Europe with moderate to advanced fibrosis due to MASH are currently under the care of liver specialists.

Rezdiffra is a once-daily, oral THR-β agonist designed to address the underlying causes of MASH. The EC’s decision was based on positive data from the Phase 3 MAESTRO-NASH trial, where the drug met both of its primary endpoints: fibrosis reduction and MASH resolution. The treatment also showed improvements in liver stiffness, liver fat, enzymes, atherogenic lipids, and patient-reported quality of life. After one year, 91% of patients on Rezdiffra showed improvement or stabilization in liver stiffness.

Dr. Frank Tacke, Chairman of Hepatology & Gastroenterology at Charité – Universitätsmedizin Berlin, called the approval a “transformational moment” for the MASH community in Europe, adding that real-world clinical experience already supports its use.

The EC decision applies across all 27 EU Member States as well as Iceland, Liechtenstein, and Norway. Madrigal plans to begin launching Rezdiffra country-by-country starting in Germany in Q4 2025, subject to local reimbursement procedures.

This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025.