Madrigal Pharmaceuticals, Inc, a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today 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. Rezdiffra is now the first and only approved therapy in the European Union (EU) for the treatment 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.”

MASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Madrigal estimates that approximately 370,000 patients with MASH with moderate to advanced fibrosis are currently diagnosed and under the care of a liver specialist across Europe.

Rezdiffra is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. The EC Decision was based on Rezdiffra’s favorable benefit-risk profile – including the positive results from the pivotal Phase 3 MAESTRO-NASH trial, which achieved both fibrosis reduction and MASH resolution primary endpoints. Rezdiffra also reduced liver stiffness, liver fat, liver enzymes, and atherogenic lipids in the MAESTRO-NASH trial, and improved health-related quality of life. At one year, 91% of patients treated with Rezdiffra 100 mg achieved improvement or stabilization of liver stiffness as measured by vibrational-controlled transient elastography (VCTE), a test that is frequently used to monitor treatment response in clinical practice.

Frank Tacke, MD, PhD, MBHA, Chairman of Hepatology & Gastroenterology at the Charité – Universitätsmedizin Berlin, Germany, stated, “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.”

This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted in June 2025. The EC Decision is valid in all 27 Member States of the EU, as well as in Iceland, Liechtenstein and Norway. The timing for access to Rezdiffra in individual countries will depend on multiple factors, including the completion of reimbursement procedures. Madrigal expects to launch Rezdiffra in Europe on a country-by-country basis commencing with Germany in the fourth quarter of 2025.

Source: globenewswire.com