Intercept's new NASH drug faces FDA delays

March 27, 2020

Intercept Pharmaceuticals announced that the FDA has rescheduled its advisory committee meeting (AdCom) to review the drugmaker's highly anticipated obeticholic acid which has the potential to be the first-ever drug for the fatty liver disease nonalcoholic steatohepatitis.

Amid the evolving COVID-19 pandemic, the FDA has rescheduled the previously announced AdCom related to Intercept's New Drug Application (NDA) for obeticholic acid in liver fibrosis due to nonalcoholic steatohepatitis (NASH) from April 22 to June 9, 2020 (tentatively).

The drugmaker says it will continue to work closely with the FDA and that the Prescription Drug User Fee Act (PDUFA) target action date for the NDA remains June 26, 2020.

Read the press release