Skyclarys* (omaveloxolone) received a positive opinion from the CHMP for the treatment of Friedreich’s ataxia

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023. Skyclarys* (omaveloxolone) received a positive opinion from the CHMP for the treatment of Friedreich’s ataxia, an inherited disease causing a range of symptoms that worsen over time, including difficulty walking, inability to co-ordinate movements, muscle weakness, speech problems, damage to the heart muscle and diabetes. 

 Skyclarys 

 INN: omaveloxolone 

Marketing-authorisation applicant: Reata Ireland Limited 

Therapeutic indication: Treatment of Friedreich’s ataxia 

Skyclarys: Pending EC decision

Biogen press release: CAMBRIDGE, Mass., Dec. 15, 2023 (GLOBE NEWSWIRE) 

Skyclarys* (omaveloxolone) received a positive opinion from the CHMP for the treatment of Friedreich’s ataxia

BIOGEN NEWS RELEASE