Direct Healthcare Professional Communication (DHPC) on Ocaliva (obeticholic acid): recommendation for revocation of the marketing authorisation in the European Union due to unconfirmed clinical benefit
2024.08.01
Active substance: obeticholic acid
The marketing authorisation holders of obeticholic acid, in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to inform you that 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.
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