Reata Pharmaceuticals, Inc. announced that the United States Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) to update the drug substance specification for SKYCLARYS®? (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.

SKYCLARYS®®? (omaveloxalone) is an oral, once-daily medication indicated for the treatment of Friedrech's ataxia in adults, adolescents aged 16 years and older in the United States. The Company's Marketing Authorization Application for omaveloxolone is under review in Europe by the European Medicines Agency (EMA).

The European Commission has granted Orphan Drug designation in Europe to omaveloxolone for the treatment of FriedreICH's ataxia. Hormonal Contrace contraceptive: Counsel females to use an alternative contraceptive method (e.g., non-hormonal intrarauterine system) or additional non-hormonal contraceptive (e.g., condoms) during concomitant use and for 28 days after discontinuation of SKYCLARYS. This is not a complete list of potential drug interactions.

Specific Population: Due to the uncertainty of any potential adverse effects on the breastfed infant, women are advised not to breastfeed during treatment with SKYCLARYS.