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

 
• By Sarah Karlin-Smith

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

A US Food and Drug Administration advisory committee voted 13-0 against approval of Reata Pharmaceuticals, Inc.’s bardoxolone to slow the loss of progression of kidney disease caused by Alport syndrome but expressed some optimism in continued study of the drug – if the company is open to taking its advice.

The Cardiovascular and Renal Drugs Advisory Committee generally agreed with FDA’s review that the sponsor did not adequately prove the...

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