EC General Court Refuses to Extend Suspension of Ocaliva Revocation

In September 2024, the European Commission (EC) revoked the Conditional Marketing Authorisation (CMA) for Advanz Pharma’s Ocaliva (obeticholic acid), a second-line treatment for patients with primary biliary cholangitis (PBC). But the General Court of the European Union temporarily suspended the EC’s decision. However, the General Court has now decided not to further extend this suspension..

Advanz Pharma has expressed disagreement with the EC’s revocation decision and is in discussions with relevant national agencies to ensure continued access to the medicine for patients who rely on Ocaliva through compassionate access or named patient programs. The overall validity of the EC decision to revoke the CMA is yet to be decided upon. The current order of the court only assessed whether there were serious damages caused to Advance Pharma by ECs decision and did not assess the patient impact or overall validity of EC decision.

Advance Pharma Statement