EU/3/17/1861: Orphan designation for the treatment of pulmonary arterial hypertension

(S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester


On 20 April 2017, orphan designation (EU/3/17/1861) was granted by the European Commission to Biological Consulting Europe Ltd, United Kingdom, for (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester (also known as KAR5585) for the treatment of pulmonary arterial hypertension.

The sponsorship was transferred to Roivant Sciences Ireland Limited, in March 2018.

The sponsorship was transferred to Altavant Sciences Ireland Limited, Ireland in May 2019.

Key facts

Active substance
(S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester
Intended use
Treatment of pulmonary arterial hypertension
Orphan designation status
EU designation number
Date of designation

Altavant Sciences Ireland Limited
9 Exchange Place
International Financial Service Centre
Dublin 1D01 X8H2

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:

  • 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:

How useful was this page?

Add your rating