Reata Pharmaceuticals Completed Rolling NDA Submission of Omaveloxolone for Friedreich’s Ataxia
April 1, 2022
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Reata Pharmaceuticals Completed Rolling NDA Submission for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. FDA for omaveloxolone’s treatment of Friedreich’s ataxia (FA). The NDA is supported by the efficacy and safety data from the MOXIe Part 1, Part 2 and MOXIe Extension studies. The FDA has granted Fast Track …