An FDA advisory committee recommended against full approval for Ocaliva (obeticholic acid) for primary biliary cholangitis by a 13-1 vote

The  FDA advisory committee recommended against full approval for Alfasigma and Intercept Pharmaceuticals’ rare liver disease drug Ocaliva by a 13-1 vote,

The sNDA was submitted to support full approval of Ocaliva and to satisfy post-marketing requirements confirming a clinical benefit in patients with PBC. "We are disappointed in the outcome of today’s Advisory Committee meeting and believe the vote does not accurately recognize the clinical benefit of Ocaliva as an important second-line therapy for patients living with PBC,” said Paul Nitschmann, M.D., Senior Vice President of Regulatory Affairs at Intercept.

With more than 42,000 years of collective real-world patient experience over eight years of being on the market, Ocaliva is the first approved second-line therapy with multiple peer-reviewed study results.   Intercept is grateful for the continuous support of the PBC community, including those patients and healthcare providers who contributed to the meeting, and will continue to work collaboratively with the FDA on behalf of patients. While the FDA will take into consideration the committee’s vote, the vote is not binding upon the agency. The FDA will make the final decision and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.