Advanz Pharma’s Ocaliva Drug Withdrawal: EU Court Upholds Revocation [Video]

Advanz Pharma’s liver disease drug Ocaliva (obeticholic acid) is no longer available in Europe. The General Court of the European Union upheld the European Commission’s decision to revoke its conditional marketing authorization (CMA).

Ocaliva received CMA in 2016, allowing its use for patients with primary biliary cholangitis (PBC) while more data was gathered. In June 2024, the European Medicines Agency (EMA) reviewed the drug’s safety and effectiveness and recommended the revocation of its CMA.

Advanz Pharma briefly suspended the EC’s decision while pursuing legal action but the General Court did not extend the suspension. This means Ocaliva is now withdrawn from all European Union member states and European Economic Area countries, including Iceland, Liechtenstein, and Norway. Advanz Pharma is still challenging the decision in court, with a ruling expected in 2025, but the revocation takes effect immediately.

The US Food and Drug Administration (FDA) has a similar position. The drug …