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Madrigal Wins Accelerated Approval for NASH Drug Rezdiffra

Becomes the first and only medication approved by the FDA for the treatment of nonalcoholic steatohepatitis.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Madrigal Pharmaceuticals, Inc. received accelerated approval from the U.S. FDA for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.   Rezdiffra is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. The accelerated appr...

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