19 August 2025 - Conditional marketing authorisation is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra reduced fibrosis, resolved MASH and improved key noninvasive tests.
Madrigal Pharmaceuticals today announced that the European Commission has granted conditional marketing authorisation for Rezdiffra (resmetirom) for the treatment of adults with non-cirrhotic MASH with moderate to advanced liver fibrosis.