EU/3/15/1574: Orphan designation for the treatment of focal segmental glomerulosclerosis

4'-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-2-sulfonamide

Overview

On 11 November 2015, orphan designation (EU/3/15/1574) was granted by the European Commission to Retrophin Europe Limited, Ireland, for 4'-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-2-sulfonamide for the treatment of focal segmental glomerulosclerosis.

The sponsor’s name was updated in March 2021. The sponsorship was transferred to Vifor France S.A., France in December 2021.

Key facts

Active substance
4'-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-2-sulfonamide
Intended use
Treatment of focal segmental glomerulosclerosis
Orphan designation status
Positive
EU designation number
EU/3/15/1574
Date of designation
11/11/2015
Sponsor

Vifor France S.A. 
Tour Franklin La Defense 8 
100-101 Terrasse Boieldieu 
92042 Paris La Defense Cedex 
France
E-mail: contact-fr@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.

Update history

DateUpdate
December 2021The sponsorship was transferred to Vifor France S.A., France.
March 2021The sponsor’s name was updated.

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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