Madrigal Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis

Core Viewpoint - Madrigal Pharmaceuticals has received conditional marketing authorization from the European Commission for Rezdiffra, making it the first approved therapy for metabolic dysfunction-associated steatohepatitis (MASH) in the European Union [1][10]. Company Overview - Madrigal Pharmaceuticals, Inc. is focused on developing novel therapeutics for MASH, a liver disease with significant unmet medical needs [12]. - Rezdiffra (resmetirom) is a once-daily, oral, liver-directed THR-β agonist designed to address the underlying causes of MASH [8][12]. Product Details - Rezdiffra is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) [9][10]. - The European Commission's decision was based on positive results from the Phase 3 MAESTRO-NASH trial, which demonstrated fibrosis reduction and MASH resolution [3][6]. - At one year, 91% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of liver stiffness [3]. Market Context - MASH is a leading cause of liver-related mortality and is increasingly burdening healthcare systems globally, with approximately 370,000 patients diagnosed in Europe [2][5]. - The approval of Rezdiffra is expected to set a precedent in the treatment of MASH, as it does not require a biopsy for treatment qualification [2][4]. Regulatory Approval - The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025 [4]. - Rezdiffra is included in European MASH treatment guidelines and is expected to launch in Germany in the fourth quarter of 2025 [4][6].