FDA Approves Omaveloxolone As First Treatment for Friedreich Ataxia
The FDA has approved omaveloxolone (Skyclarys), an agent developed by Reata Pharmaceuticals for the treatment of Friedreich ataxia in adults and adolescents aged 16 years and older, making it the first and only therapy approved for the indication.1 In the supporting trial data, treatment with omaveloxolone resulted in statistically significant lower modified Friedreich Ataxia Rating Scale (mFARS) scores relative to placebo at Week 48, accounting for a placebo-corrected difference between the groups of –2.41 points (P = .0138). The therapy,…