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

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