Ocaliva officially pulled off European market

UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe.

This cover European Union member states as well as in the European Economic Area countries Iceland, Liechtenstein and Norway) for second-line treatment of patients with the rare liver disease primary biliary cholangitis (PBC).

The decision 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.