FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia


The FDA has assigned a Prescription Drug User Fee Act target action date of Nov. 30, 2022. Regulators indicated they plan to hold an advisory committee meeting to discuss the application.

The FDA has accepted for filing and granted priority review of the new drug application for Reata Pharmaceuticals’ omaveloxolone for the treatment of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, genetic, degenerative neuromuscular disorder. If approved, the company anticipates omaveloxolone will be available in early 2023.

Patients with Friedreich’s ataxia typically experience symptoms in childhood, including progressive loss of coordination, muscle weakness, and fatigue that commonly results in motor incapacitation with patients requiring a wheelchair in their 20s. It impacts about 5,000 children and adults in the United States and 22,000 individuals globally. Currently, there are no approved therapies for the treatment of Friedreich’s ataxia.

Omaveloxolone is an investigational, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.

The NDA is supported by the efficacy and safety data from the MOXIe Part 2 trial and additional supporting data from the MOXIe Part 1 and MOXIe Extension trials.

Omaveloxolone received Fast Track Designation in November 2021 and Rare Pediatric Disease Designation in May 2022.

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