EU/3/19/2147: Orphan designation for the treatment of primary sclerosing cholangitis
2-[3-(2-chloro-4-{[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy}phenyl)-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1)
Table of contents
Overview
On 1 April 2019, orphan designation (EU/3/19/2147) was granted by the European Commission to Gilead Sciences Ireland UC, Ireland, for 2-[3-(2-chloro-4-{[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy}phenyl)-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1) (also known as GS-9674) for the treatment of primary sclerosing cholangitis.
Key facts
Active substance |
2-[3-(2-chloro-4-{[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy}phenyl)-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1)
|
Intended use |
Treatment of primary sclerosing cholangitis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/19/2147
|
Date of designation |
01/04/2019
|
Sponsor |
Gilead Sciences Ireland UC |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
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: