13 November 2024 - Intercept Pharmaceuticals today announced that the US FDA has issued a complete response letter that addresses the supplemental new drug application for Ocaliva (obeticholic acid) seeking full approval for the treatment of indicated patients with primary biliary cholangitis – a rare, progressive disease that disproportionally affects women.

The FDA informed Intercept that it is unable to approve the supplemental new drug application in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee meeting in September 2024. In its letter, the FDA also said it was continuing to consider safety data from the 747-302 study, along with other safety information.

Read Intercept Pharmaceuticals press release