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FDA Approves SKYCLARYS for Patients with Friedreich’s Ataxia

Rare pediatric disease priority review voucher granted.

Reata Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the U.S. Food and Drug Administration (“FDA”) has cleared SKYCLARYS (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With the approval, the FDA granted a rare pediatric disease priority review voucher. The company said that it is completing the commercial drug product m...

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