Ocaliva (obeticholic acid): recommendation for revocation of the marketing authorisation in the European Union due to unconfirmed clinical benefit.

Summary

• The phase 3 confirmatory Study 747-302 (COBALT) of Ocaliva in primary biliary cholangitis (PBC) patients did not confirm the clinical benefit of Ocaliva. 
• As a consequence, the benefit-risk balance of Ocaliva is no longer favourable and its marketing authorisation in the EU has been recommended for revocation.
• No new patients should be started on Ocaliva outside of a clinical trial. For patients currently on treatment with Ocaliva, available treatment options should be considered.