Madrigal Receives Positive CHMP Opinion for Resmetirom (Rezdiffra™) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis

Core Viewpoint - Madrigal Pharmaceuticals has received a positive opinion from the CHMP of the EMA recommending approval of resmetirom (Rezdiffra) for treating adults with noncirrhotic MASH with moderate to advanced liver fibrosis, with a decision from the European Commission expected in August 2025 [1][2][7] Company Overview - Madrigal Pharmaceuticals is focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease with high unmet medical need [16] - Resmetirom is the first approved medication for MASH in the U.S. and is designed as a once-daily, oral, liver-directed THR-β agonist [7][16] Product Details - Resmetirom has shown positive results in the pivotal Phase 3 MAESTRO-NASH trial, achieving both fibrosis improvement and MASH resolution primary endpoints [2][8] - In the U.S., resmetirom is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) in conjunction with diet and exercise [8][10] Industry Context - MASH is a leading cause of liver-related mortality and is the fastest-growing indication for liver transplantation in Europe [4][5] - The prevalence of MASH is expected to increase as awareness improves, leading to a growing number of diagnosed patients with moderate to advanced fibrosis or compensated MASH cirrhosis [6]