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

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.

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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 revealed in December that it was told by the agency to prepare for an advisory committee and that the action date for the OCA new drug application (NDA) had been pushed back 90 days from 26 March to 26 June to allow for a panel likely to occur on 22 April

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