EU/3/19/2147

About

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)
Disease / condition
Treatment of primary sclerosing cholangitis
Date of first decision
01/04/2019
Outcome
Positive
EU designation number
EU/3/19/2147

Review of designation

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

Sponsor's contact details

Gilead Sciences Ireland UC
Ida Business & Technology Park
Carrigtohill T45 DP77
Ireland
Tel.: +353 (0)21 4825500
E-mail: regulatory.orphan@gilead.com

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.

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