FDA grants priority review for Friedreich’s ataxia treatment

The FDA has granted priority review to Reata Pharmaceuticals Inc.’s new drug application for omaveloxolone to treat patients with Friedreich’s ataxia.

According to a company press release, the NDA is supported by positive safety and efficacy data from the MOXIe part 2 trial as well as supporting data from MOXIe part 1 and MOXIe extension trials.

Omaveloxolone (RTA 408, Reata), an oral, once-daily anti-inflammatory therapeutic, received fast track designation in November 2021 and rare pediatric disease designation in May 2022. The priority review designation shortens the FDA’s review of an NDA to 8 months from the time of submission.

“We are pleased with the FDA’s decision to grant priority review to our NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia in the United States,” Warren Huff, Reata CEO, said in the release. “With the FDA’s acceptance of our NDA for filing, omaveloxolone is now one step closer to potentially providing a treatment option for patients with Friedreich’s ataxia, a rare, genetic, debilitating and degenerative neuromuscular disorder with no approved therapies.”

Pending FDA approval, Reata expects to launch omaveloxolone commercially in early 2023.