Reata Pharmaceuticals Initiates Rolling Submission of New Drug Application with U.S. FDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia

Plans to Complete Submission by the End of the First Quarter of 2022

If Approved, Omaveloxolone Would Become the First Therapy Indicated for the Treatment of Patients with Friedreich’s Ataxia

PLANO, Texas--(BUSINESS WIRE)-- Reata Pharmaceuticals, Inc. (Nasdaq: RETA), (“Reata,” the “Company,” “our,” “us,” or “we”), a clinical-stage biopharmaceutical company, today announced that the company has initiated a rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. The rolling submission allows Reata to submit portions of the regulatory application to the FDA for review on an ongoing basis. The company reiterates that it expects to complete the submission of the NDA by the end of the first quarter of 2022.

“Today’s announcement marks an important milestone in our efforts to advance the first therapy for patients with Friedreich’s ataxia, a serious and devastating disease,” said Warren Huff, Reata’s President and Chief Executive Officer. “I want to thank all the patients, families, and investigators who participated in the MOXIe trial and the extension phase of the study. We appreciate the FDA’s recognition of the potential of omaveloxolone for patients with Friedreich’s ataxia through its Fast Track Designation and guidance on the contents of the NDA.”

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