By Colin Kellaher

Intercept Pharmaceuticals shares fell sharply Wednesday after U.S. Food and Drug Administration briefing documents ahead of Friday's advisory committee meeting to discuss the biopharmaceutical company's resubmitted application for obeticholic acid showed the agency has concerns about the drug's safety.

Shares of the Morristown, N.J., company, were recently changing hands at $13.09, down 19%.

Intercept is once again seeking FDA approval of obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to the chronic liver condition nonalcoholic steatohepatitis, commonly known as NASH.

The FDA's briefing documents for the meeting showed that the agency has concerns over potential risks of liver injury and diabetes from the drug.

The FDA's panel of outside advisers is slated to vote on whether the drug's benefits outweigh its risks, and if they would recommend approval under an accelerated pathway based on currently available data or a deferral until data from an ongoing study are submitted and reviewed.

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.

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.

There are currently no FDA-approved products for NASH, a progressive disease that is a leading cause of liver transplant.

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

(END) Dow Jones Newswires

May 17, 2023 11:50 ET (15:50 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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