Reata Pharmaceuticals Announces FDA Approval of SKYCLARYS™ (Omavaloxolone), the First and Only Drug Indicated for Patients with Friedreich’s Ataxia

FRIEDREICH’S ATAXIA IS AN ULTRA-RARE, PROGRESSIVE, NEUROMUSCULAR DISEASE THAT AFFECTS APPROXIMATELY 5,000 DIAGNOSED PATIENTS IN THE UNITED STATES

SKYCLARYS IS INDICATED FOR THE TREATMENT OF FRIEDREICH’S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER

RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER GRANTED

MANAGEMENT TO HOST CONFERENCE CALL TODAY, FEBRUARY 28, 2023, AT 6:00 PM ET

PLANO, Texas--(BUSINESS WIRE)-- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), 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 approved SKYCLARYS™ (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With this approval, the FDA granted a rare pediatric disease priority review voucher.

"The approval of SKYCLARYS, the first therapy specifically indicated for the treatment of Friedreich’s ataxia, is an important milestone for patients affected by this disease as well as their families and caregivers," said Warren Huff, Reata's Chief Executive Officer. "We are grateful to Friedreich’s ataxia patients, investigators, U.S. regulators, and our scientists and employees who made this approval possible. As a company, this is a transformative milestone that highlights our commitment to developing and commercializing novel therapies for patients with severe diseases with few or no approved therapies. We look forward to delivering SKYCLARYS to eligible patients as quickly as possible."

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