Reata Pharmaceuticals Completed Rolling NDA Submission for Omaveloxolone for Friedreich’s Ataxia
Reata Pharmaceuticals (RETA) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. FDA for omaveloxolone’s treatment of Friedreich’s ataxia (FA). The NDA is supported by the efficacy and safety data from the MOXIe Part 1, Part 2 and MOXIe Extension studies.
The FDA has granted Fast Track Designation and Orphan Drug Designation to omaveloxolone for the treatment of Friedreich’s ataxia.
Why is This Important for Patients with Friedreich’s Ataxia?
Patients with Friedreich’s ataxia experience symptoms from childhood which include progressive loss of coordination, muscle weakness and fatigue resulting in motor incapacitation. The patients require wheelchairs in their teens or early 20s.
Patients with Friedreich’s ataxia may also experience visual impairment, hearing loss, diabetes and cardiomyopathy.