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

Executive Summary

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 was expecting positive results from a Phase III study by Japanese licensee for diabetic kidney disease after a US rejection for Alport Syndrome last year, but the US company and Asia partner Kyowa Kirin have now decided to end development in CKD indications after a missed secondary endpoint seen as critical to approval in Japan. 

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