In surprise turn, FDA adcomm votes in favor of Ardelyx CKD drug despite agency questions

After the FDA rejected and questioned Ardelyx’s potential drug for the control of serum phosphorus levels in adults with chronic kidney disease on dialysis, the FDA’s Cardiovascular and Renal Drugs advisory committee on Wednesday voted 9-4 in favor of the drug as a monotherapy, and 10-2 (with one abstention) in favor of the drug when administered in combo with phosphate binder treatment.