Priority Review for Intercept's OCA in PBC

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said FDA accepted and granted Priority Review to an NDA for obeticholic acid ( OCA; DSP-1747) to treat primary biliary cirrhosis. The PDUFA date is Feb. 29, 2016.

The oral farnesoid X receptor (FXR; NR1H4) agonist has Orphan Drug designation in the U.S. and EU to treat PBC and primary sclerosing cholangitis (PSC). FDA has also granted OCA Fast Track designation to treat PBC and breakthrough therapy designation to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. The compound is under EMA review. ...