FDA Calls for Pre-NDA Meeting with Reata Over Omaveloxolone

Reata Pharmaceuticals said the FDA has asked the company to seek a meeting with the agency ahead of its New Drug Application for omaveloxolone as a treatment for Friedreich’s ataxia, a rare, inherited neuromuscular disease.

Omaveloxone activates Nrf2, a transcription factor that reduces inflammation by restoring proper mitochondrial function. There are currently no approved therapies for Friedreich’s ataxia, which is normally diagnosed during adolescence.

The European Commission has granted omaveloxolone Orphan Drug designation in Europe for the treatment of the disease.