Tuesday, February 28, 2023
Reata Pharmaceuticals 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.
The approval of SKYCLARYS, is the first therapy specifically indicated for the treatment of Friedreich’s ataxia, and is an important milestone for patients affected by this disease as well as their families and caregivers.
SKYCLARYS™ (omaveloxolone) is an oral, once-daily medication indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older in the U.S. SKYCLARYS has received Orphan Drug, Fast Track, and Rare Paediatric Disease Designations from the FDA. The European Commission has granted Orphan Drug designation in Europe to omaveloxolone for the treatment of Friedreich’s ataxia.
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.
