FDA approves new indication for Ardelyx's tenapanor for serum phosphorus control
Nearly a year after successfully appealing a complete response letter, Ardelyx won FDA approval on Tuesday for Xphozah (tenapanor) for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis who have had an inadequate response or intolerance to phosphate binder therapy.
The about-face from the FDA follows an advisory committee vote of 9-4 last November in favor of Xphozah in this indication. The committee said the twice-daily tablet might have less efficacy than the current standard of care, but it should be made available to a small subset of patients with CKD.
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