Ocaliva filed at EMA to treat fibrosis due to NASH and FDA sets advisory committee meeting date.- Intercept Pharma.

Intercept Pharmaceuticals, Inc. announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH). The MAA submission is supported by the positive interim analysis results from the pivotal Phase III REGENERATE study in patients with liver fibrosis due to NASH.

Intercept also announced that the FDA has notified the company of the tentative date for the previously announced advisory committee meeting (AdCom) related to Intercept�s New Drug Application (NDA) for OCA in liver fibrosis due to NASH. The FDA has tentatively scheduled the AdCom for April 22, 2020. Intercept anticipates that the FDA accordingly will extend the recently announced March 26, 2020 Prescription Drug User Fee Act (PDUFA) target action date for Intercept�s NDA. Intercept previously announced the FDA�s acceptance of the NDA and granting of priority review.