Madrigal Pharmaceuticals completes submission of NDA to U.S. FDA for resmetirom

Madrigal Pharmaceuticals announced the completion of the rolling submission of its New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for resmetirom for the treatment of adults with NASH with liver fibrosis, a disease with no approved therapy. Madrigal has requested a priority review of the resmetirom NDA. Resmetirom is a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver. The clinical development program for resmetirom is comprised of 18 clinical studies supporting the NDA: twelve Phase 1 studies, two Phase 2 studies, and four Phase 3 studies. Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “Based on the positive efficacy results observed in MAESTRO-NASH and the large safety database we have established across the MAESTRO trials, we believe resmetirom has the potential to become the first approved treatment for patients with NASH with liver fibrosis, a disease that is rapidly becoming the leading cause of liver transplantation in the U.S. Madrigal has generated a robust evidence package to support the FDA’s benefit-risk evaluation and our two ongoing Phase 3 outcomes studies, one of which is already fully enrolled, reflect our commitment to verifying clinical benefit following a potential accelerated approval.”