BRIEF-FDA confirms use of mFARS as main goal in MOXIe trial can support omaveloxolone approval in Friedreich’s Ataxia
Aug 14 (Reuters) - Reata Pharmaceuticals Inc
* FDA confirms that use of mFARS as primary endpoint in part 2 of the MOXIe trial can support approval of omaveloxolone in Friedreich’s Ataxia
* Says ‍primary endpoint of trial will be change from baseline in mFARS of omaveloxolone compared to placebo at 48 weeks​
* Reata Pharmaceuticals Inc says ‍initiated screening patients for part 2 of MOXIe and plans to randomize first patient during second half of 2017​
* Reata Pharmaceuticals - ‍FDA indicated that it may consider either accelerated or full approval based on overall results of trial and strength of data​
* Reata pharma- FDA recommended co extend treatment duration for part 2 of study, add a straightforward patient-reported or performance-based outcome endpoint Source text for Eikon: Further company coverage: