Madrigal Pharmaceuticals, Inc. announced that the Company?s Marketing Authorization Application (MAA) for resmetirom for the treatment of NASH/metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis has been validated and is now under evaluation with the European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Resmetirom is a once-daily, oral, liver-directed THR-ß agonist designed to target key underlying causes of NASH.

The clinical development program for resmetirom is comprised of 18 clinical studies supporting the MAA: twelve Phase 1 studies, two Phase 2 studies, and four Phase 3 studies. The pivotal MAESTRO-NASH trial of resmetirom is the only Phase 3 trial in NASH to achieve both fibrosis reduction and NASH resolution primary endpoints, an efficacy standard for NASH therapies described in the EMA?s Reflection Paper on Regulatory Requirements for the Development of Medicinal Products for Chronic Non-infectious Liver Diseases. In the United States, resmetirom received Breakthrough Therapy designation from the FDA and was granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date of March 14, 2024, the target date by which FDA intends to complete its review.