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Madrigal Pharmaceuticals Says Marketing Authorization Application for Resmetirom Validated by EMA
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Madrigal Pharmaceuticals Says Marketing Authorization Application for Resmetirom Validated by EMA
Mar 5, 2024 9:50 AM

12:26 PM EST, 03/05/2024 (MT Newswires) -- Madrigal Pharmaceuticals ( MDGL ) said Tuesday its marketing authorization application for resmetirom in treating nonalcoholic steatohepatitis with liver fibrosis has been validated by the European Medicines Agency.

Resmetirom's marketing authorization application is currently under evaluation by the European Medicines Agency's Committee for Medicinal Products for Human Use, Madrigal said.

Resmetirom is an oral therapy designed to target key underlying causes metabolic dysfunction-associated steatohepatitis. It is under priority review by the the US Food and Drug Administration, with a target action date set for March 14, the company said.

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