EU/3/19/2182: Orphan designation for the treatment of primary biliary cholangitis



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.

Key facts

Active substance
Intended use
Treatment of primary biliary cholangitis
Orphan designation status
EU designation number
Date of designation

Ipsen Pharma
65 Quai Georges Gorse
92100 Boulogne-Billancourt

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Update history

Date Update
September 2022 The sponsorship was transferred from Genfit, France to Ipsen Pharma, France in September 2022.

Documents related to this orphan designation evaluation

Patients' organisations

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:

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