TAK-831 for Friedreich Ataxia. Withdrawn from the Union Register of orphan medicinal products in November 2019

20/11/2019. European Medicines Agency.
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Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2019 on request of the Sponsor.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
Disease / condition: Treatment of Friedreich’s ataxia
Date of first decision:  01/04/2019
Outcome: Withdrawn
EU designation number: EU/3/19/2148


https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3192148#review-of-designation-section