Madrigal Pharmaceuticals has secured the European Commission’s (EC) conditional marketing authorisation for Rezdiffra (resmetirom) to treat metabolic dysfunction-associated steatohepatitis (MASH), a type of fatty liver disease.
Rezdiffra is an oral THR-β agonist. It has been approved by the EC for treating adults with noncirrhotic MASH having moderate to advanced liver fibrosis.
According to Madrigal, Rezdiffra is the first therapy approved in the European Union (EU) for the treatment of MASH.
The EC approval is valid across all EU member states, along with Iceland, Liechtenstein, and Norway.
Madrigal plans to launch Rezdiffra in Germany in Q4 2025, with plans for further rollouts across Europe.
Madrigal CEO Bill Sibold said: “This approval of Rezdiffra marks a historic breakthrough for patients in Europe living with MASH, a serious and progressive liver disease. MASH is the fastest-growing indication for liver transplantation in Europe, but until now, had no approved treatment.
“The European labelling for Rezdiffra will set an important precedent for the entire field, with no biopsy required to qualify for treatment with Rezdiffra and a clear focus on a distinct MASH patient population with high unmet need: those with moderate to advanced fibrosis (F2-F3).
“These patients require liver-directed treatment because they have a 10 to 17 times higher risk of liver-related mortality and are just one or two steps away from progressing to cirrhosis.”
The EC decision follows positive outcomes from the Phase 3 MAESTRO-NASH trial, which showed significant improvements in fibrosis and MASH resolution.
In the MAESTRO-NASH trial, Rezdiffra showed a positive benefit-risk profile.
The trial showed reductions in liver stiffness, fat, enzymes, and atherogenic lipids, along with improved health-related quality of life.
Rezdiffra is not yet approved for treating patients with cirrhosis, as ongoing trials are assessing its efficacy in those indications.
Charité – Universitätsmedizin hepatology and gastroenterology chairman Frank Tacke said: “The approval of Rezdiffra is a transformational moment for the European MASH community, and I’m looking forward to offering this important new treatment option to my patients with moderate to advanced fibrosis.
“Rezdiffra is included in the European MASH treatment guidelines and hundreds of patients participated in the Phase 3 studies, so there is already sound clinical experience with Rezdiffra in Europe.”
Recently, Madrigal entered into a global licensing agreement with CSPC Pharmaceutical for the latter’s oral GLP-1 receptor agonist, SYH2086.
Madrigal expects the Rezdiffra and SYH2086 combination to provide a potential once-daily, well-tolerated MASH treatment.
