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Madrigal Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis
Rezdiffra is the first and only medication approved for people living with MASH in the European Union Conditional marketing authorization is based on positive
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"Rezdiffra is the first and only medication approved for people living with MASH in the European Union Conditional marketing authorization is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra reduced fibrosis, resolved MASH and improved key noninvasive testsRezdiffra is already included in European MASH treatment guidelines as a first-line treatmentMadrigal is planning for its first European launch in Germany in the fourth quarter of 2025 CONSHOHOCKEN, Pa., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), 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-NAS...