Posted by Michael Wonder on 01 Apr 2022
Reata Pharmaceuticals completes rolling submission of new drug application for omaveloxolone for the treatment of patients with Friedreich’s ataxia
31 March 2022 - If approved, omaveloxolone would become the first therapy indicated for the treatment of patients with Friedreich’s ataxia.
Reata Pharmaceuticals today announced the completion of the rolling submission of a new drug application to the U.S. FDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia. This new drug applicaton 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 designation and orphan drug designation to omaveloxolone for the treatment of Friedreich’s ataxia.
