Reata Pharmaceuticals Inc (NASDAQ: RETA) completed a mid-cycle communication meeting with the FDA regarding the marketing application review status for omaveloxolone for Friedreich's ataxia.
The FDA stated that it had not identified any new significant issues, but it continues to have concerns regarding the strength of the efficacy evidence.
The agency did not identify any significant clinical safety issues.
The FDA stated that the safety review is ongoing, and they are continuing to evaluate the cardiac safety of omaveloxolone in patients with Friedreich's ataxia, a rare genetic disease that causes difficulty walking.
They have not identified any other major safety concerns at this stage of their review.
The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of November 30.
Results of the updated Delayed-Start Analysis from the March 2022 data cut-off demonstrated that the between-group difference in Friedreich's ataxia scale was observed at the end of the placebo-controlled MOXIe Part 2 treatment preserved at MOXIe Extension Week 72 in the delayed-start period.
The threshold for non-inferiority was met at Extension Week 120.
Reata held a cash balance of $481.5 million.
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