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 manufacturing and anticipate commercial drug supply of SKYCLARYS to be available in the second quarter of 2023.

“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 CEO. “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.”

Friedreich’s ataxia is an ultra-rare, inherited neurodegenerative disorder that is typically diagnosed during adolescence. Patients with Friedreich’s ataxia experience progressive loss of coordination, muscle weakness, and fatigue, which commonly progresses to motor incapacitation and wheelchair reliance by their teens or early twenties, and eventually death. Friedreich’s ataxia affects approximately 5,000 diagnosed patients in the U.S.

According to Reata Pharmaceuticals, the approval of SKYCLARYS is supported by the efficacy and safety data from the MOXIe Part 2 trial and a post hoc propensity-matched analysis of the open-label MOXIe Extension trial.

The company also announced the launch of the Reata Education, Access, and Care Helpline (REACH), an integrated specialty pharmacy and patient services program, designed to help eligible patients access prescribed Reata medicines. For additional information about REACH programs call 1-844-98-REACH or visit www.reataREACH.com.