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Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
Madrigal expects to complete full submission of the New Drug Application in July 2023 CONSHOHOCKEN, Pa., June 30, 2023 (GLOBE NEWSWIRE) -- Madrigal
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"Madrigal expects to complete full submission of the New Drug Application in July 2023 CONSHOHOCKEN, Pa., June 30, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis. Madrigal has submitted the majority of the NDA to the FDA and plans to submit the remaining components in July 2023. The company will request a priority review of the NDA. Resmetirom was granted Breakthrough Therapy designation in April 2023 for the treatment of patients with NASH with liver fibrosis. As a result, Madrigal was allowed to submit individual sections of its NDA as they were completed rather than waiting until the entire application was complete. Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “In the MAESTRO-NASH biopsy trial, resmetirom achieved both liver histological improvement endpoints proposed by FDA as reasonably likely to predict clinical benefit and demonstrated a well-tolerated safety profile. We believe the positive results from MAESTRO-NASH support the potential of resmetirom to become a foundational therapy for NASH with liver fibrosis. The MAESTRO development program will provide a robust data package to support the FDA’s review of the resmetirom NDA.” Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “Madrigal is committed to addressing the needs of patients who currently have no approved treatments for NASH with liver fibrosis and the NDA submission for resmetirom is an important milestone. We look forward to working closely with the FDA as the review process progresses.” About the Resmetirom Phase 3 Registration Program for the Treatment of NASH Madrigal is currently conducting four Phase 3 clinical trials to demonstrate the safety and efficacy of resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE, and MAESTRO-NASH-OUTCOMES. MAESTRO-NASH is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of resmetirom in patients with liver biopsy-confirmed NASH and was initiated in March 2019. The...