An FDA advisory panel raised concerns over the efficacy of Intercept Pharmaceuticals' liver disease drug, which is awaiting the regulator's traditional approval.

The panel, in briefing documents published on the FDA's website, said the confirmatory trial for the drug did not provide evidence that it was effective in patients with primary biliary cholangitis (PBC).

Intercept's oral drug, Ocaliva (obeticholic acid), received an accelerated approval from the FDA in 2016 as a treatment for PBC. In 2021, the FDA restricted use of the drug to PBC patients who did not have advanced cirrhosis or severe scarring of the liver.

Intercept is now hoping to convert the accelerated nod, which comes with the caveat of a confirmatory trial, into a traditional approval.

FDA advisers said that an analysis of Ocaliva's confirmatory trial did not show that it was effective in PBC patients with or without advanced cirrhosis.

The comments come ahead of a meeting, where independent experts will discuss and vote on the drug's confirmatory trial data.