Intercept announces GIDAC meeting on OCA scheduled for May 19

Intercept Pharmaceuticals announced that the Gastrointestinal Drugs Advisory Committee of the U.S. Food and Drug Administration will discuss Intercept’s new drug application for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis on May 19, 2023. The Advisory Committee Meeting will be hosted as a virtual meeting. As previously reported, the Prescription Drug User Fee Act target action date is June 22, 2023. The timeline for review of the NDA by FDA remains subject to change.