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)

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
Ida Business & Technology Park
Carrigtohill T45 DP77
Ireland
E-mail: harley.besser@gilead.com

Review of designation

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

Documents related to this orphan designation evaluation

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:

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