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.
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Reata says partner Kyowa Kirin’s outcomes study of bardoxolone in chronic kidney disease may address the questions cited by the FDA in its complete response letter for Alport syndrome.
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