Positive recommendation based on resmetirom’s favorable profile including positive results from the pivotal Phase 3 MAESTRO-NASH trial
Madrigal Pharmaceuticals, a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency 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.
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Bill Sibold, Chief Executive Officer of Madrigal, stated, “Madrigal is singularly focused on leading the fight against MASH globally. 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 we believe resmetirom has the potential to address the urgent unmet need for a foundational, liver-directed therapy to treat patients with this serious disease.”
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MASH 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-β agonist designed to target key underlying causes of MASH. The CHMP opinion was based on resmetirom’s favorable profile including the positive results from the pivotal Phase 3 MAESTRO-NASH trial, which achieved both fibrosis reduction and MASH resolution primary endpoints.
Jörn M. Schattenberg, M.D., Professor of Medicine and Director of the Department of Medicine at the University Medical Center Homburg and University of the Saarland in Germany, stated, “I’m encouraged by the CHMP’s positive opinion recommending approval of resmetirom. After years of clinical research and growing appreciation of the burden of MASH on patients and health systems across Europe, we are finally on the cusp of having an approved therapy that targets the underlying disease. Importantly, resmetirom is already included in European clinical practice guidelines, which provide a framework for identifying and monitoring patients with noninvasive tests. 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
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Source – GlobeNewswire
