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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

Reata Pharmaceuticals, Inc.’s failure to listen to the US FDA’s trial design advice looks likely to sink its rare disease chronic kidney disease treatment bardoxolone at the company’s 10 December advisory committee meeting. The agency believes the company’s sole Phase III study was not designed to adequately evaluate the potential of bardoxolone to slow the progression of decline in kidney function.

Reata is seeking approval of bardoxolone to slow the loss of progression of kidney disease caused by Alport syndrome in patients 12 and older.

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