Reata’s Bardoxolone Shot Down, But US FDA Advisors Offer Suggestions For Improved Study

Advisory committee unanimously votes against bardoxolone for Alport syndrome, unconvinced drug slows progression of chronic kidney disease and concerned about safety signals suggesting it could make the disease worse. However, panel offers Reata suggestions for a better-designed trial.

healthy and chronic kidney diseased kidney
FDA advisors offered Reata a path forward for more studies of its chronic kidney disease drug. • Source: Alamy

More from US FDA Performance Tracker

More from Regulatory Trackers