EMA recommends withdrawal of Ocaliva marketing authorisation for PBC

The European Medicines Agency recommends the withdrawal of the marketing authorisation of Ocaliva for the treatment of primary biliary cholangitis - Statement from the European Reference Network for Rare and Complex Liver Diseases, ERN RARE-LIVER.

The European Medicines Agency (EMA) today recommended the recall of Ocaliva, a medicine provisionally authorised since 2016 for the treatment of adults with primary biliary cholangitis (PBC). The provisional authorisation was granted on the condition that the benefits of the medicine were confirmed in a long-term study. The data from this study has now been carefully analysed by the European Medicines Agency, and the assessment together with international experts and patient representatives, including representatives of the ERN RARE-LIVER, has led to a re-evaluation of the risks and benefits of the drug.

Addiotinal details:https://www.ema.europa.eu/en/news/ema-recommends-revoking-conditional-marketing-authorisation-ocaliva