CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom), marking the first approved treatment in the European Union (EU) for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.
The approval positions Rezdiffra as a landmark therapy for patients suffering from a progressive liver disease that has been a leading driver of liver transplants in Europe. According to Madrigal, approximately 370,000 diagnosed MASH patients with moderate to advanced fibrosis are currently under specialist care across Europe.
Groundbreaking Treatment for a Growing Health Crisis
Rezdiffra, a once-daily oral, liver-directed THR-β agonist, targets the underlying causes of MASH and offers the first real therapeutic option for a patient population at significantly higher risk of liver-related mortality.
“This approval of Rezdiffra marks a historic breakthrough for patients in Europe living with MASH,” said Bill Sibold, Madrigal’s Chief Executive Officer. “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 conditional marketing authorization follows positive results from the pivotal Phase 3 MAESTRO-NASH trial, which demonstrated Rezdiffra’s ability to reduce fibrosis, resolve MASH, and improve key noninvasive test outcomes. Among other findings, 91% of patients receiving a 100 mg dose showed improvement or stabilization of liver stiffness after one year, measured via vibrational-controlled transient elastography (VCTE).
Inclusion in European Guidelines and Clinical Adoption
Rezdiffra has already been integrated into European MASH treatment guidelines as a first-line therapy. Clinical specialists across the continent are preparing for its rollout, beginning with Germany in the fourth quarter of 2025.
“The approval of Rezdiffra is a transformational moment for the European MASH community,” said Dr. Frank Tacke, Chairman of Hepatology & Gastroenterology at Charité – Universitätsmedizin Berlin. “There is already sound clinical experience with this treatment in Europe, given the hundreds of patients who participated in the Phase 3 studies.”
Market Access and Next Steps
The European Commission’s decision applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway. Madrigal plans a country-by-country launch, starting with Germany later this year, while reimbursement negotiations will determine access timelines elsewhere in Europe.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025 and is expected to reshape the treatment landscape for MASH, a disease placing an increasing strain on healthcare systems globally.
With Rezdiffra’s entry into the EU market, Madrigal Pharmaceuticals positions itself at the forefront of liver disease innovation, offering hope to patients previously left without therapeutic options.
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