On 25 July 2019, orphan designation EU/3/19/2182 was granted by the European Commission to Genfit, France, for elafibranor for the treatment of primary biliary cholangitis.
Treatment of primary biliary cholangitis
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
|September 2022||The sponsorship was transferred from Genfit, France to Ipsen Pharma, France in September 2022.|
Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: