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Could Postponement of Intercept’s Expected NASH Panel Impact Its PDUFA Date?

 
• By Joseph Haas

CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.

Building icon with inscription FDA and flag of The United States over abstract background. - Illustration
The status of imminent advisory committee reviews is in question with CDER's meeting cancellation notice

Ramifications of the novel coronavirus COVID-19 continue to bring business interruptions for the biopharmaceutical industry, including the 10 March announcement by the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) that all external meetings through the end of April are being postponed. For Intercept Pharmaceuticals Inc., that likely means a later date than expected for the advisory committee review of obeticholic acid (OCA) for non-alcoholic steatohepatitis (NASH).

The FDA did not respond to an inquiry about the status of Intercept advisory committee, which is widely expected – but not yet formally scheduled – for 22 April. Intercept...

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