Madrigal Gets FDA Priority Review of Resmetirom in NASH With Liver Fibrosis
13 September 2023 - 11:56PM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 13, 2023 09:41 ET (13:41 GMT)
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