EU/3/14/1373: Orphan designation for the treatment of granulomatosis with polyangiitis
(2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan)
Table of contents
Overview
On 19 November 2014, orphan designation (EU/3/14/1373) was granted by the European Commission to ChemoCentryx Limited, United Kingdom, for (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide for the treatment of granulomatosis with polyangiitis (avacopan).
This medicine is now known as avacopan.
The sponsorship was transferred to Chemocentryx Ireland Limited, Ireland, in February 2019.
The sponsorship was transferred to Vifor Fresenius Medical Care Renal Pharma France in October 2020.
Avacopan has been authorised in the EU as Tavneos since 11 January 2022.
Key facts
Active substance |
(2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan)
|
Intended use |
Treatment of granulomatosis with polyangiitis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/14/1373
|
Date of designation |
19/11/2014
|
Sponsor |
Vifor Fresenius Medical Care Renal Pharma France |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
The Committee for Orphan Medicinal Products reviewed the orphan designation of Tavneos at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the Orphan Medicine Assessment Report.
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: