FDA slaps CRL on Ocaliva sNDA

Intercept Pharmaceuticals, now wholly owned subsidiary of Italy’s Alfasigma, today revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women.

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

Intercept said that Ocaliva continues to be available for the treatment of appropriate patients living with PBC in the USA under accelerated approval status.