Madrigal Receives EC Conditional Approval For Rezdiffra In Noncirrhotic MASH With Liver Fibrosis
Author: Benzinga Newsdesk | August 19, 2025 04:10pm
- Rezdiffra is the first and only medication approved for people living with MASH in the European Union
- Conditional marketing authorization is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra reduced fibrosis, resolved MASH and improved key noninvasive tests
- Rezdiffra is already included in European MASH treatment guidelines as a first-line treatment
- Madrigal is planning for its first European launch in Germany in the fourth quarter of 2025
CONSHOHOCKEN, Pa., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra is now the first and only approved therapy in the European Union (EU) for the treatment of MASH.
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