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
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