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European Medicines Association (EMA) statement on Obeticholic acid (Ocaliva) for the treatment of primary biliary cholangitis (PBC)


The European Medicines Association (EMA) issued a statement on Obeticholic acid (Ocaliva) for the treatment of primary biliary cholangitis (PBC) on 28 06 2024. 

The EMA has recommended that the marketing authorisation for Ocaliva be revoked in the European Union following results of the COBALT trial, 747-302 .  In the UK EMA recommendations do not apply, as we are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). At present, there are no changes to the recommendations on use of Obeticholic acid in PBC from the MHRA or the National Institute for Health and Care Excellence (NICE) and so current prescribing practices should NOT change.

We shall update the UK liver community if there are any changes to the recommendations on the use of Obeticholic acid.

View the full statement here.

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