The European Medicines Agency’s (EMA) human medicines committee (CHMP) is recommending that the marketing authorisation for a liver disease drug be revoked because its benefits are no longer considered to outweigh its risks.
EMA says a recent study has failed to confirm that the Ocaliva – obeticholic acid – is effective at treating PBC, an autoimmune condition that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer.
The agency will now send the CHMP opinion to the European Commission, which will issue in due course a final legally binding decision applicable in all EU member states.
The study failed to show that Ocaliva was more effective than placebo in terms of the number of patients whose disease worsened or who died, both in the overall population and in a group of patients with early stage PBC.
The committee considered that the data from supportive studies and real-world data were not sufficient to confirm the benefits of Ocaliva and could not counterbalance the negative results of the study.
The CHMP therefore concluded that the benefits of Ocaliva do not outweigh its risks and recommended that its marketing authorisation be revoked in the EU.
