Reata Pharmaceuticals gets approval of prior approval supplement for SKYCLARYS

Reata Pharmaceuticals “announced that the FDA has approved the Prior Approval Supplement to update the drug substance specification for SKYCLARYS, or omaveloxolone, the first and only FDA approved drug for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With the approval of the PAS, SKYCLARYS is now available to patients with Friedreich’s ataxia in the United States.”