Biopharmaceutical company Reata Pharmaceuticals, Inc. (RETA) announced Wednesday that it received a communication from the Division of Neurology Products 1 of the U.S. Food and Drug Administration stating that, after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-NDA meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich’s ataxia.
The Division suggested that the Company withdraw the current meeting request for a Type C meeting and instead request a pre-NDA meeting, which the Division will grant upon receipt.
The Division asked the Company to focus the new briefing package on questions, issues, and needs applicable to a pre-NDA meeting.
As requested by the FDA, the Company plans to withdraw the current request for a Type C meeting and submit a request for a pre-NDA meeting as soon as practicable.
Friedreich’s ataxia is a rare, inherited, life-shortening, debilitating, and degenerative neuromuscular disorder, which is normally diagnosed during adolescence.
This disorder affects approximately 5,000 children and adults in the U.S. and 22,000 individuals globally. There are currently no approved therapies for the treatment of the disorder.
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 and the European Commission have granted Orphan Drug designation to omaveloxolone for the treatment of Friedreich’s ataxia.
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