FDA accepts Intercept's NDA for OCA for the treatment of liver fibrosis due to NASH and grants priority review.

Intercept Pharmaceuticals, Inc. announced that the FDA has accepted Intercept's New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH) and granted priority review. The FDA grants priority review to drugs that have the potential to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 26 March 2020 for the NDA. In the NDA filing acceptance notification letter, the FDA also indicated that it currently plans to hold an advisory committee meeting to discuss the application. A date for the advisory committee meeting has not been finalized and the timeline for the review of the NDA by the FDA remains subject to change.