European Court Suspends EC’s Decision to Revoke Ocaliva’s Marketing Authorization

Temporary Suspension:
The General Court of the European Union has temporarily suspended the European Commission's decision to revoke the marketing authorization for Ocaliva, a drug used to treat primary biliary cholangitis (PBC).

Continued Availability:
This suspension means that Ocaliva will continue to be available in the EU for both new and existing patients until further guidance is provided by the General Court.

Background:
The European Medicines Agency (EMA) recommended revoking Ocaliva's marketing authorization in June 2024, citing that its risks outweigh its benefits. The European Commission (EC) subsequently revoked the authorization on September 3, 2024.

Advanz Pharma's Response:
Advanz Pharma, the company behind Ocaliva, disagreed with the EC's decision and is considering all options to ensure continued access to the treatment. The company argues that the EMA did not adequately consider the totality of available data, including real-world evidence.

Patient Impact:
The removal of Ocaliva could have a profoundly negative impact on the lives of thousands of PBC patients across Europe who have benefited from this treatment over many years.