Shots:
- The US FDA has granted accelerated approval to Rezdiffra for treating noncirrhotic NASH with moderate to advanced liver fibrosis (F2 to F3) supported by the P-III (MAESTRO-NASH) study assessing its safety & efficacy at 100mg & 80mg dosing vs PBO in NASH patients (n=1,759)
- The results after 52wks. showed improved NASH resolution (incl. a ≥2 points reduction in the NAFLD activity score) without worsening fibrosis & fibrosis improvement by at least one stage without worsening NAFLD activity score
- The MAESTRO-NASH study continues for full approval while a 2nd study is underway to assess the progression to liver decompensation events in well-compensated NASH cirrhosis patients treated with Rezdiffra vs PBO
Ref: Madrigal Pharmaceuticals | Image: Madrigal Pharmaceuticals | Press Release
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