1 October 2021 - - US-based biopharmaceutical company Reata Pharmaceuticals, Inc. (NASDAQ: RETA) has completed its pre-New Drug Application meeting with the United States Food and Drug Administration for omaveloxolone for the treatment of patients with Friedreich's ataxia and reaffirmed its plan to submit an NDA in 1Q22, the company said.

The purpose of the pre-NDA meeting was to discuss the content of Reata's planned NDA submission.

The company plans to submit the NDA seeking standard approval for omaveloxolone for the treatment of Friedrich's ataxia.

According to the company, the FDA indicated that the appropriate approval pathway would be a matter of review after submission of the NDA.

In response to our questions about the contents of the filing and because of the seriousness of the indication, the FDA exercised its discretion subject to review to permit us to submit the results of certain nonclinical and clinical studies after approval.

Friedreich's ataxia is a rare, inherited, life-shortening, debilitating, and degenerative neuromuscular disorder, which is normally diagnosed during adolescence.

Friedreich's ataxia is caused by a trinucleotide repeat expansion in the first intron of the frataxin gene, which encodes the mitochondrial protein frataxin.

There are currently no approved therapies for the treatment of patients with 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 FDA has granted Orphan Drug designation to omaveloxolone for the treatment of Friedreich's ataxia. The European Commission has granted Orphan Drug designation in Europe to omaveloxolone for the treatment of Friedreich's ataxia.

Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation.

Reata's two most advanced clinical candidates, bardoxolone methyl and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.

The company possesses exclusive, worldwide rights to develop, manufacture, and commercialize bardoxolone, omaveloxolone, and our next-generation Nrf2 activators, excluding certain Asian markets for bardoxolone in certain indications, which are licensed to Kyowa Kirin Co., Ltd.

Bardoxolone and omaveloxolone are investigational drugs.