Madrigal Gains European Commission Approval For Rezdiffra™ (resmetirom) To Treat MASH Patients With Moderate To Advanced Liver Fibrosis

Madrigal Pharmaceuticals, Inc., a biopharmaceutical company developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. With this decision, Rezdiffra becomes the first and only approved therapy in the European Union (EU) for the treatment of MASH.

MASH is a leading cause of liver-related deaths and represents a growing challenge for healthcare systems worldwide. Madrigal estimates that approximately 370,000 patients in Europe with moderate to advanced fibrosis caused by MASH are currently diagnosed and being treated by liver specialists. Rezdiffra, a once-daily oral therapy, is a liver-directed THR-β agonist designed to target the key drivers of MASH progression. The EC’s decision was supported by a favorable benefit-risk profile and positive data from the Phase 3 MAESTRO-NASH trial, which met both of its primary endpoints: improvement in liver fibrosis and resolution of MASH.

Bill Sibold, Chief Executive Officer of Madrigal, stated, “This approval of Rezdiffra marks a historic breakthrough for patients in Europe living with MASH, a serious and progressive liver disease. MASH is the fastest-growing indication for liver transplantation in Europe, but until now, had no approved treatment. The European labelling for Rezdiffra will set an important precedent for the entire field, with no biopsy required to qualify for treatment with Rezdiffra and a clear focus on a distinct MASH patient population with high unmet need: those with moderate to advanced fibrosis (F2-F3). These patients require liver-directed treatment because they have a 10 to 17 times higher risk of liver-related mortality and are just one or two steps away from progressing to cirrhosis.”

Frank Tacke, MD, PhD, MBHA, Chairman of Hepatology & Gastroenterology at the Charité – Universitätsmedizin Berlin, Germany, mentioned, “The approval of Rezdiffra is a transformational moment for the European MASH community and I’m looking forward to offering this important new treatment option to my patients with moderate to advanced fibrosis. Rezdiffra is included in the European MASH treatment guidelines and hundreds of patients participated in the Phase 3 studies, so there is already sound clinical experience with Rezdiffra in Europe.”

In addition to meeting these primary goals, Rezdiffra demonstrated further clinical benefits in the trial, including reductions in liver stiffness, liver fat, liver enzymes, and atherogenic lipids, as well as improvements in quality of life measures. After one year of treatment, 91% of patients receiving Rezdiffra 100 mg showed either stabilization or improvement in liver stiffness, as measured by vibrational-controlled transient elastography (VCTE), a widely used tool for monitoring liver disease progression in clinical practice.

The EC approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in June 2025. The authorization is valid in all 27 EU Member States, along with Iceland, Liechtenstein, and Norway. Market access will depend on reimbursement processes within each country, and Madrigal plans to initiate launches in Europe on a phased, country-by-country basis, starting with Germany in the fourth quarter of 2025.