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
Table of contents
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Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2019 on request of the Sponsor.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Withdrawn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 |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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: