ADVANZ PHARMA Responds To European Commission’s Decision To Lift Suspension On OCALIVA® Approval

ADVANZ PHARMA Holdco Limited, a UK-based pharmaceutical company, has announced that the General Court of the European Union has decided not to extend the temporary suspension of the European Commission’s decision to revoke the conditional marketing authorisation (CMA) for OCALIVA® (obeticholic acid) in Europe. This decision was made after the temporary suspension granted on September 5, 2024.

As a result, the European Commission’s decision to revoke the CMA for OCALIVA® is now in effect, meaning the drug will no longer be authorised for use in the European Union and European Economic Area countries (Iceland, Liechtenstein, and Norway) for the treatment of primary biliary cholangitis (PBC). The General Court’s ruling only focused on whether the EC's decision caused "serious" or "irreparable" harm to ADVANZ PHARMA, without considering the impact on patients or the overall validity of the EC decision. A full review of the decision’s validity is still ongoing, with a final ruling expected in 2025.

Steffen Wagner, CEO at ADVANZ PHARMA, said in a statement, “We are very disappointed by the General Court’s decision. OCALIVA® is a much-needed treatment option for thousands of patients with PBC in Europe. As an FXR agonist, OCALIVA® has a different mechanism of action from other treatments and is backed by a wealth of positive real-world evidence, gathered from more than seven years of clinical use. Without OCALIVA®, patients could be at increased risk of disease progression, including serious liver harm, liver transplantation, or death. ADVANZ PHARMA disagrees with the EC revocation decision and remains committed to supporting patients with PBC and is in discussion with relevant national agencies to enable continued access for patients who rely on this medicine.”

The European Medicines Agency (EMA) has stated that ADVANZ PHARMA may still be able to provide OCALIVA® in Europe, following local laws and regulations, through a compassionate access or named patient programme for current patients. ADVANZ PHARMA is dedicated to supporting patients and will make sure the drug is available based on the approval of the national health authorities.