EU/3/19/2148: Orphan designation for the treatment of Friedreich’s ataxia

4-hydroxy-6-{2-[4-(trifluoromethyl)phenyl]ethyl}pyridazin-3(2H)-one

Overview

On 1 April 2019, orphan designation (EU/3/19/2148) was granted by the European Commission to Takeda Pharma A/S, Denmark, for 4-hydroxy-6-{2-[4-(trifluoromethyl)phenyl]ethyl}pyridazin-3(2H)-one (also known as TAK-831) for the treatment of Friedreich’s ataxia.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2019 on request of the Sponsor.

Key facts

Active substance
4-hydroxy-6-{2-[4-(trifluoromethyl)phenyl]ethyl}pyridazin-3(2H)-one
Intended use
Treatment of Friedreich’s ataxia
Orphan designation status
Withdrawn
EU designation number
EU/3/19/2148
Date of designation
01/04/2019
Sponsor

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark
Tel. +45 46 77 1036
E-mail: info@takeda.dk

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:

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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