Madrigal Pharmaceuticals, Inc. Receives Positive Chmp Opinion for Resmetirom (Rezdiffra??) for the Treatment of Mash with Moderate to Advanced Liver Fibrosis

Published: 2025-06-20 07:20:27 ET MDGL

Published on 06/20/2025 at 07:20

Madrigal Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of resmetirom (Rezdiffra) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. The European Commission decision is anticipated in August. Resmetirom was the first medication to achieve fibrosis improvement and MASH resolution in a Phase 3 trial, the first medication to receive FDA-approval for MASH, and today's positive CHMP opinion represents another historic first for the global MASH community.

MASH is the fastest-growing indication for liver transplantation in Europe, and believe resmetirom has the potential to address the urgent unmet need for a foundational, liver-directed therapy to treat patients with this serious disease." If approved, I believe the medication has the potential to transform care for my patients with MASH. The U.S. Food and Drug Administration (FDA) granted accelerated approval in March 2024 for Rezdiffra in conjunction with diet and exercise for the treatment of adults with Noncirrhotic MASH With moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or may also report side effects to Madrigal at 1-800-905-0324. Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-b antagonist designed to target key underlying causes of MASH.

Rezdiffra is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stage F4c). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F 4c).