Public summary of opinion on orphan designation: Omaveloxolone for treatment of Friedreich's ataxia

EMA/395368/2018, 16 August 2018

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.
In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the COMP adopted a positive opinion on 24 May 2018 recommending the granting of this designation.

 Public summary of opinion on orphan designation: Omaveloxolone for treatment of Friedreich's ataxia