EU Court of Law Upholds EC Decision to Revoke OCA License in EU

The conditional marketing authorisation for OCALIVA® across the EU and EEA has been revoked with immediate effect.

This means that the EC’s revocation decision is in force, resulting in the CMA for OCALIVA® being revoked in Europe (EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway) with immediate effect.

The General Court Order only assessed whether there were “serious” and “irreparable” or “irreversible” damages to ADVANZ PHARMA caused by the EC decision, and did not assess patient impact or the overall validity of the EC decision. The overall validity of the EC decision is subject to an ongoing annulment procedure at the General Court which has not yet been ruled upon, and is anticipated in 2025.

Steffen Wagner, CEO at ADVANZ PHARMA, commented: “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 has referenced the ability for ADVANZ PHARMA to continue – subject to local laws and regulations – to supply OCALIVA® in Europe on a compassionate access or named patient programme basis for existing patients. ADVANZ PHARMA is committed to supporting patients and will ensure supplies are available depending on national competent authority approved provisions.