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MARCH 1, 2023

FDA Approves Skyclarys for Friedreich’s Ataxia


Originally published by our sister publication Specialty Pharmacy Continuum

By SPC Staff 

The FDA approved omaveloxolone (Skyclarys, Reata Pharmaceuticals) as the first treatment for Friedreich’s ataxia

The drug is indicated for adults and adolescents aged 16 years and older. It is taken orally once a day at a recommended dose of 150 mg. The FDA also granted a Rare Pediatric Disease Priority Review Voucher for omaveloxolone. 

Friedreich’s ataxia affects about 5,000