EU/3/20/2387: Orphan designation for the treatment of primary biliary cholangitis
Table of contents
On 6 January 2021, orphan designation EU/3/20/2387 was granted by the European Commission to GenKyoTex S.A, France, for setanaxib for the treatment of primary biliary cholangitis.
Treatment of primary biliary cholangitis
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
|August 2022||The sponsor's name was changed from GenKyoTex S.A. to Calliditas Therapeutics France S.A.S in August 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: