Unforced Error: Reata’s Decision To Ignore US FDA Endpoint Advice May Haunt Bardoxolone

 
• By Sarah Karlin-Smith

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.

women with fingers in her ears
Reata’s decision to ignore FDA trial design advice likely to backfire. • Source: Alamy

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