Research & Development
Reata Pharmaceuticals Notified of a Three Month Extension of the Review Period for New Drug Application for Omaveloxolone for the Treatment of Friedreich's Ataxia
9 August 2022 - - US-based biopharmaceutical company Reata Pharmaceuticals, Inc. (NASDAQ: RETA) has received a communication from the US Food and Drug Administration informing the company that they have extended the review timeline for the New Drug Application for omaveloxolone for the treatment of Friedreich's ataxia by three months, the company said.

The company said it recently submitted an updated Delayed-Start Analysis of the MOXIe Extension study using a March 2022 data cut-off, a new Propensity-Matched Analysis of MOXIe Extension data using patient data from the Clinical Outcome Measures in Friedreich's Ataxia Study as controls, and an analysis of the relevance of Nrf2, the target of omaveloxolone, to the pathophysiology of Friedreich's ataxia.

These submissions were provided as confirmatory evidence of the results of the MOXIe Part 2 study in response to concerns raised by the FDA during the mid-cycle communication meeting.

FDA determined that these submissions were a major amendment to the company's NDA and extended the Prescription Drug User Fee Act date to provide time for a full review of the new data and analyses.

The updated PDUFA date for the application is February 28, 2023.

The FDA put the planned advisory committee meeting on hold pending review of the new NDA amendments.

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, Fast Track, and Rare Pediatric Disease Designations 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. An NDA for omaveloxolone for the treatment of Friedreich's ataxia is currently under review by the FDA.

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, omaveloxolone and bardoxolone methyl, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. 

Omaveloxolone and bardoxolone are investigational drugs, and their safety and efficacy have not been established by any agency.
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