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NEWS

Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis

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 Q4’25Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…
August 20, 2025

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Madrigal Pharmaceuticals
NEWS

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…
March 14, 2024

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