EU/3/14/1373

About

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.

Key facts

Active substance
(2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan)
Disease / condition
Treatment of granulomatosis with polyangiitis
Date of decision
19/11/2014
Outcome
Positive
Orphan decision number
EU/3/14/1373

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

Chemocentryx Ireland Limited
70 Sir John Rogerson's Quay
Dublin 2
Co. Dublin
Ireland
Tel: +353 1 232 2000
E-mail: regulatory@chemocentryx.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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