Unforced Error: Reata’s Decision To Ignore US FDA Endpoint Advice May Haunt Bardoxolone
Advisory committee will vet FDA argument that even though the chronic kidney disease drug met its endpoints, the trial design didn’t allow Reata to demonstrate that bardoxolone slows decline in kidney function. Safety concerns and COVID-19 trial disruptions also likely to prove worrisome.
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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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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.