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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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June 03, 2025

Spring 2025 BSG Elections Results

The spring 2025 BSG elections results are now in! Check out who your new elected members and representatives are.

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May 27, 2025

Notice of Annual General Meeting 2025

Notice is hereby given that the Annual General Meeting (Meeting) of the British Society of Gastroenterology (Company) will be held at the Scottish Event Campus (SEC), Exhibition Way, Glasgow G3 8YW, on Wednesday 25 June 2025 at 6.10pm, in Room M1.

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May 09, 2025

Congratulations to Dr Christopher Mountford; the new BSG Secretary

Congratulations to Dr Christopher Mountford, the new BSG Secretary.