Intercept submits OCA NDA

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said it submitted an NDA to FDA for accelerated approval of OCA obeticholic acid to treat primary biliary cirrhosis (PBC). The company also said EMA accepted for review an MAA for OCA to treat PBC.

The oral farnesoid X receptor (FXR; NR1H4) agonist has Orphan Drug designation from FDA and EMA, as well as Fast Track designation from FDA, in the indication. ...