Gastrointestinal Drugs Advisory Committee

On Thursday, April 7, 2016, the Gastrointestinal Drugs Advisory Committee (GIDAC) unanimously supported, by a vote of 17-Yes to 0-No, with no abstentions, the safety and efficacy of obeticholic acid for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, submitted by Intercept Pharmaceuticals, Inc. (Intercept).

The Prescription Drug User Fee Act (PDUFA) goal date for the related new drug application is May 29, 2016.