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.
Congratulations to Dr Christopher Mountford; the new BSG Secretary
Congratulations to Dr Christopher Mountford, the new BSG Secretary.
Help Shape the Future of GI Physiology – National Data Collection Open (May–June 2025)
The second National Data Collection for GI Physiology services will run from Monday 12th May to Friday 6th June 2025.
BSG Inflammatory Bowel Disease Surveillance Guideline 2025
Our newly updated guideline for colorectal surveillance for patients with IBD is now available, providing a comprehensive road map for evidence-based, expert management of the whole pathway to try and prevent or detect bowel cancer early for this higher risk patient group.