Shots:
- The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25
- Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which met its 1EPs of fibrosis improvement & MASH resolution, plus showed reduced liver stiffness, liver fat, liver enzymes, & atherogenic lipids, with 91% pts on 100mg showing improvement or stabilization in liver stiffness
- Rezdiffra is being evaluated in a fully enrolled, ongoing P-III (MAESTRO-NASH OUTCOMES) trial against PBO to assess its impact on liver decompensation in MASH cirrhosis
Ref: Madrigal Pharmaceuticals| Image: Madrigal Pharmaceuticals| Press Release
Related News:- Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis
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