EU/3/18/2037: Orphan designation for the treatment of Friedreich’s ataxia
Omaveloxolone
Table of contents
Overview
On 27 June 2018, orphan designation (EU/3/18/2037) was granted by the European Commission to Dr Stefan Blesse, Germany, for omaveloxolone (also known as RTA 408) for the treatment of Friedreich's ataxia.
The sponsorship was transferred to Granzer Regulatory Consulting & Services, in November 2019.
The sponsorship was transferred to Reata Ireland Limited, Ireland, in August 2021.
Key facts
Active substance |
Omaveloxolone
|
Intended use |
Treatment of Friedreich’s ataxia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/18/2037
|
Date of designation |
27/06/2018
|
Sponsor |
Reata Ireland Limited Block A George's Quay Plaza |
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
Date | Update |
---|---|
January 2023 |
The sponsor's address was updated. |
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: