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)

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.

Key facts

Active substance
(2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan)
Intented 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
Tour Franklin La Defense 8
100 Terrasse Boieldieu
Paris La Defense Cedex
92042
France
Tel: +33180041636
E-mail: laure.strande@viforpharma.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:

  • 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:

Related content

How useful was this page?

Add your rating