FDA Pushed Back PDUFA Date on Omaveloxolone

The FDA has pushed back its decision date on Reata Pharmaceuticals’ New Drug Application (NDA) for omaveloxolone, an investigational drug for treatment of the rare inherited neurodegenerative disease Friedreich’s ataxia.

Reata said the FDA has concerns regarding the strength of the efficacy data. The agency previously expressed similar concerns in November 2020.

The company has submitted new data that they agency views a major amendment to the NDA, and has moved the decision date from Nov. 30 to Feb. 28, 2023.

The drug is an oral, once-daily activator of Nrf2, a transcription factor that restores mitochondrial function, reducing oxidative stress and inhibiting inflammation.

The FDA has granted omaveloxolone Fast Track, Orphan Drug and Rare Pediatric Disease designations.