Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis
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 | Image: Madrigal
Related News:- Madrigal Pharmaceuticals Reports the EMA’s Validation for the MAA of Resmetirom to Treat NASH/MASH with Liver Fibrosis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
