Madrigal Gets FDA Priority Review of Resmetirom in NASH With Liver Fibrosis

By Colin Kellaher

Madrigal Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking approval of its lead drug candidate resmetirom for certain patients with nonalcoholic steatohepatitis, a chronic liver condition commonly known as NASH.

The West Conshohocken, Pa., clinical-stage biopharmaceutical company on Wednesday said the application covers resmetirom for the treatment of adults with NASH with liver fibrosis.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Madrigal said the FDA assigned a target action date of March 14, 2024, for the application, adding that the agency isn't currently planning to hold an advisory committee meeting.

Madrigal said an FDA green light would make resmetirom the first approved treatment for patients with NASH with liver fibrosis.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 13, 2023 09:41 ET (13:41 GMT)

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