Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration

As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).

Liver disease

With US Food and Drug Administration approval of Rezdiffra (resmetirom) for metabolic-associated steatohepatitis (MASH) with fibrosis, Madrigal Pharmaceuticals, Inc. now faces the challenge of developing the market for MASH, while it awaits competitors who will claim to offer efficacy, safety and/or tolerability advantages.

The FDA granted accelerated approval 14 March for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH, also known as...

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