The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive recommendation for the conditional authorisation of Rezdiffra (resmetirom), developed by Madrigal Pharmaceuticals, for the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis and no cirrhosis. If approved by the European Commission, Rezdiffra would be the first authorised treatment in the European Union for this form of fatty liver disease.
Rezdiffra previously received regulatory approval in the United States in March 2024. In the European Union, there are currently no approved therapies available for MASH, previously referred to as non-alcoholic steatohepatitis (NASH). The condition is marked by excessive fat buildup in the liver, which leads to inflammation and the formation of scar tissue.
According to the EMA, the drug is intended for use in patients experiencing moderate to advanced liver scarring caused by fat accumulation. Rezdiffra works by targeting the thyroid hormone receptor beta (THR-β) in the liver. This activation reduces fat content in the liver, helps alleviate inflammation, and may help to slow or prevent additional liver damage in individuals diagnosed with MASH.
The CHMP’s recommendation was issued under the European Union’s conditional marketing authorisation framework. This process is intended to provide earlier access to medicines addressing unmet medical needs. Under this framework, a product may be recommended based on less complete clinical data than is typically required, provided the potential advantages of immediate availability for patients outweigh associated uncertainties. Madrigal stated that a final decision by the European Commission is expected by August.
In a conference call held earlier this month, Madrigal Pharmaceuticals stated its plans to begin commercialising Rezdiffra in Europe, starting with Germany in the second half of 2025, following the anticipated authorisation. The company also noted that resmetirom had already been integrated into European clinical practice guidelines, which aid in patient identification and monitoring through noninvasive testing approaches.
The CHMP opinion was supported by the results of the pivotal Phase 3 MAESTRO-NASH trial. According to Madrigal, the trial met both of its primary endpoints—fibrosis reduction and MASH resolution—contributing to the EMA’s favorable stance.
Madrigal’s Chief Executive Officer, Bill Sibold, said, “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.”
Jörn M. Schattenberg, M.D., Professor of Medicine and Director at the University Medical Center Homburg and University of the Saarland in Germany, noted that following extended clinical investigation and growing awareness of the disease burden across Europe, the CHMP’s opinion brings the region close to having a treatment option that directly targets the disease.
Rezdiffra is formulated as a once-daily oral therapy and is designed to address fundamental disease mechanisms associated with MASH by acting on the liver. In the United States, the drug was granted accelerated approval for use alongside diet and exercise in adults with noncirrhotic MASH and liver fibrosis classified as stage F2 or F3. Ongoing confirmatory trials will determine continued regulatory approval in that market.
