Intercept fails to win FDA panel backing for NASH drug (updated)

Editor's note: Updated at 505p ET with results of second vote.

An independent group of advisors to the FDA overwhelmingly voted on Friday that the benefits of Intercept Pharmaceuticals' (NASDAQ:ICPT) liver disease candidate obeticholic acid (OCA) for nonalcoholic steatohepatitis (NASH) do not outweigh the risks.

Only two members of the FDA's Gastrointestinal Drugs Advisory Committee voted that the benefits outweigh the risks. Twelve members did not agree the benefits outweigh the risks. Two individuals abstained.

A second vote was 15-1 in favor of deferring approval of OCA until the data from the 747-303 trial are submitted and reviewed, and then the traditional approval pathway would be considered.

The FDA's advisory committees issue non-binding recommendations. However, the agency follows them before giving a final decision on marketing applications which, in the case of OCA, is expected on or before June 22, 2023.

On Wednesday, the FDA reviewers issued briefing documents before the meeting, raising their concerns on the risk-benefit profile of OCA. The farnesoid X receptor (FXR) agonist is already marketed as Ocaliva for the rare autoimmune disease primary biliary cholangitis.

Intercept (ICPT) shares were on hold for trading on Friday on account of the meeting.

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