Shots:
- The CHMP has recommended Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with mod. to advanced liver fibrosis; the EC’s decision is expected by Aug 2025
- Opinion 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, with 91% pts on Rezdiffra (100mg) showing improvement or stabilization in liver stiffness; data was published in The NEJM
- 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: Globenewswire | Image:Madrigal Pharmaceuticals| Press Release
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