On 9 October 2015, orphan designation (EU/3/15/1560) was granted by the European Commission to FGK Representative Service GmbH, Germany, for N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide for the treatment of Duchenne muscular dystrophy.
This medicine is now known as edasalonexent.
Please note that this product was withdrawn from the Union Register of orphan medicinal products in September 2021 upon request of the Sponsor.
Treatment of Duchenne muscular dystrophy
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Review of designation
Documents related to this orphan designation evaluation
EU/3/15/1560: Public summary of opinion on orphan designation: N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide for the treatment of Duchenne muscular dystrophy (PDF/216.55 KB)
First published: 18/11/2015
Last updated: 02/09/2021
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: