EU/3/14/1372: Orphan designation for the treatment of microscopic polyangiitis (avacopan)

(2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide

Overview

This medicine is now known as avacopan.

On 19 November 2014, orphan designation (EU/3/14/1372) 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 microscopic polyangiitis.

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)amNide
Intented use
Treatment of microscopic polyangiitis (avacopan)
Orphan designation status
Positive
EU designation number
EU/3/14/1372
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.

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

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:

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