(See below for more detailed information about MOXIe)
After consultation with regulatory advisors, FARA plans to submit a letter to both Reata and the Food and Drug Administration (FDA) that requests they work together to provide access to omaveloxolone for individuals with Friedreich's Ataxia as soon as possible. The letter will highlight the voice of the patient with a request for Reata to submit a marketing application to the FDA and for the FDA to review and consider approval of this application. The strength of this letter will depend in large part on input and testimony from the FA community. The voices and lived experiences of this community matter and will help add critical perspective and context to the MOXIe trial data points that are being discussed. Even if you did not participate in this clinical trial, it is important to hear your voices too. It is crucial that our response is respectful, informative, and representative of the FA patient experience.
We are at an important crossroads in Reata's development of omaveloxolone as a potential treatment for FA. Our clinical investigators and FARA have confidence in the data from the completed studies and would like FDA to use tools given to it under the law to exercise regulatory flexibility to avoid a delay of at least several years for access which would occur if Reata conducts another clinical trial prior to the drug being approved for use by FA patients in the U.S. Please register for this important session and learn how you can participate. Please also share this message within the FA community. The greater our unity, the stronger our message. more...
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