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Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
CONSHOHOCKEN, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"CONSHOHOCKEN, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), 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 (THR)-β 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. In the pivotal Phase 3 MAESTRO-NASH serial liver biopsy trial, resmetirom achieved both liver histological improvement endpoints – resolution of NASH and reduction of liver fibrosis – proposed by FDA as reasonably likely to predict clinical benefit to support accelerated approval for the treatment of NASH with liver fibrosis. Throughout the development program resmetirom appeared generally safe and well-tolerated. In both MAESTRO-NASH and the phase 3 safety study MAESTRO-NAFLD-1, atherogenic lipids and lipoproteins, including LDL cholesterol and triglycerides, were reduced by resmetirom and patients achieved potentially meaningful improvements in noninvasive measures of liver health. In April 2023, resmetirom was granted Breakthrough Therapy designation by FDA for the treatment of adults with NASH with liver fibrosis. 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...