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

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...