CONSHOHOCKEN, PA — The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Madrigal Pharmaceuticals’ (NASDAQ: MDGL) resmetirom (marketed as Rezdiffra) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. A final decision from the European Commission is expected in August.
Resmetirom is a once-daily, liver-directed treatment designed to target key drivers of MASH, a condition that leads to progressive liver damage and is the fastest-growing indication for liver transplantation in Europe. The recommendation by CHMP follows the drug’s groundbreaking results in the Phase 3 MAESTRO-NASH trial, where resmetirom met its primary goals of fibrosis improvement and MASH resolution.
“Madrigal is singularly focused on leading the fight against MASH globally,” said Bill Sibold, Chief Executive Officer of Madrigal. “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.”
MASH, formerly known as nonalcoholic steatohepatitis (NASH), is a severe liver disease linked to metabolic dysfunction. It is a leading cause of liver-related mortality and increases the risk of liver failure and cardiovascular disease. Patients with moderate to advanced fibrosis face a significantly elevated risk of liver-related death and complications, underscoring the need for effective early treatment.
“I’m encouraged by the CHMP’s positive opinion recommending approval of resmetirom,” said 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. “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.”
Resmetirom was previously granted FDA approval in the United States in 2024 for the treatment of noncirrhotic MASH with moderate to advanced fibrosis, with continued approval contingent on confirmatory clinical trials. Madrigal is also conducting the MAESTRO-NASH OUTCOMES trial to evaluate the drug’s potential in patients with compensated MASH cirrhosis.
The EMA’s upcoming decision could mark a pivotal moment for MASH patients in Europe, providing a long-needed therapeutic option for a condition that not only devastates individual lives but also strains healthcare systems globally.
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