FDA committee recommends Ocaliva (obeticholic acid) for primary biliary cholangitis- Intercept Pharmaceuticals

The FDA’s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva (obeticholic acid), from Intercept Pharmaceuticals, for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29, 2016.

The Advisory Committee’s recommendation is based on data from the clinical development program for Ocaliva in PBC, including the Phase III POISE trial, which assessed the safety and efficacy of Ocaliva in 216 PBC patients who had an inadequate therapeutic response to, or were unable to tolerate, UDCA. Intercept’s New Drug Application (NDA) includes data for 432 PBC patients who have received Ocaliva with an amassed total of 675 patient years of exposure and some patients on therapy for over five years. In accordance with the FDA guidelines for accelerated approval, Intercept is currently enrolling COBALT, a global Phase IV long-term outcomes trial to confirm the clinical benefit of Ocaliva in people living with PBC.