ARTICLE | Clinical News

Obeticholic acid regulatory update

September 7, 2015 7:00 AM UTC

Intercept said FDA accepted and granted Priority Review to an NDA for obeticholic acid to treat primary biliary cirrhosis (PBC). The PDUFA date is Feb. 29, 2016. The oral farnesoid X receptor (FXR; NR1H4) agonist is under EMA review for PBC. ...