European Advisory Panel Backs Conditional Approval For Madrigal's Fatty Liver Disease Drug

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted on Friday a positive opinion recommending approval for Madrigal Pharmaceuticals, Inc.’s (NASDAQ:MDGL) resmetirom (Rezdiffra) for adults with noncirrhotic MASH with moderate to advanced liver fibrosis.

EMA has recommended granting a conditional marketing authorization, said a press release.

The European Commission decision is anticipated in August.

Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, need for liver transplantation and premature mortality.

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The CHMP opinion was based on resmetirom’s favorable profile, including the positive results from the ...