Intercept Says FDA Sets AdCom Meeting on Obeticholic Acid

By Colin Kellaher

Intercept Pharmaceuticals Inc. on Friday said the U.S. Food and Drug Administration will hold an advisory committee meeting to discuss the biopharmaceutical company's resubmitted application seeking approval of obeticholic acid.

The Morristown, N.J., company, which is once again seeking an FDA green light for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to the chronic liver condition nonalcoholic steatohepatitis, commonly known as NASH, said the panel plans to meet on May 19.

The FDA in 2020 rejected Intercept's initial application for obeticholic acid, saying the company's efficacy data didn't sufficiently outweigh potential risks.

Intercept conducted additional studies and resubmitted the application in December, and the agency in January set a target action date of June 22 for a decision.

The FDA often relies on advisory committees to provide independent advice when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective, and the panels make non-binding recommendations that the agency generally follows, although it isn't legally bound to do so.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 10, 2023 09:50 ET (14:50 GMT)

Intercept Pharmaceuticals (NASDAQ:ICPT)
Historical Stock Chart
From Mar 2024 to Apr 2024