17.09.2024 - Current information on marketability

By its order of September 4, 2024 in Case T-455/24 R, the President of the General Court of the European Union temporarily suspended the Commission's implementing decision of August 30, 2024 revoking the conditional marketing authorization for Ocaliva. According to this decision, the marketing authorization for Ocaliva remains valid for the time being. The European Medicines Agency (EMA) will provide further updates as necessary.

01.07.2024 - CHMP opinion

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has completed its review of Ocaliva (obeticholic acid) and recommended that the marketing authorization for the medicine be withdrawn because the benefits of the medicine do not outweigh its risks. Ocaliva is used to treat adults with primary biliary cholangitis (PBC), an autoimmune disease that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer.

13.10.2023 - Procedure started

EMA ’s human medicines committee (CHMP) has started a review of the medicine Ocaliva (obeticholic acid), used to treat adults with primary biliary cholangitis (PBC).

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Ocaliva