FDA staff raises efficacy concerns over Intercept's liver disease drug-March 2024-www.financetom.com

FDA staff raises efficacy concerns over Intercept's liver disease drug

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FDA staff raises efficacy concerns over Intercept's liver disease drug

Sep 11, 2024 6:11 AM

Sept 11 (Reuters) - The U.S. Food and Drug Administration's staff on

Wednesday raised efficacy concerns over Intercept Pharmaceuticals' liver disease

drug, which is awaiting traditional approval.

The reviewers, 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 a rare condition called primary biliary cholangitis

(PBC).

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