Intercept's Cirrhosis Endpoint Gets FDA Panel Nod For Accelerated Approval

FDA advisory committee members backed accelerated approval of Intercept Pharmaceuticals Inc.'s Ocaliva (obeticholic acid) for primary biliary cirrhosis but suggested modifications to an ongoing confirmatory trial, as well as additional post-marketing studies, may be needed to address uncertainties left in the wake of the lone Phase III trial.

At an April 7 meeting, the Gastrointestinal Drugs Advisory Committee voted 17-0 that there is substantial evidence to support accelerated approval of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid in adults with