FDA will not hold advisory committee meeting to discuss NDA for Friedreich’s ataxia drug

Reata Pharmaceuticals Inc. announced the FDA does not plan to hold an advisory committee meeting to discuss the company’s new drug application for an investigational therapeutic to treat Friedreich’s ataxia.

Omaveloxolone is an 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, according to a company release.

The FDA previously had granted orphan drug, fast track and rare pediatric disease designations for omaveloxolone. The agency granted priority review for the drug in May.

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, the release stated.

It is estimated that Friedreich’s ataxia affects approximately 5,000 children and adults in the United States and 22,000 individuals globally, according to the release. Currently, there are no approved therapies to treat the disease.

“Friedreich’s ataxia is a rare, genetic, debilitating and degenerative neuromuscular disorder with no approved therapies, and we are committed to our goal of working to secure approval for omaveloxolone for patients living with this severe disease,” Warren Huff, Reata CEO, said in the release.