FDA Advisory Committee votes that the benefits of Xphozah outweigh its risks for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis
Ardelyx, Inc. announced the vote of the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for Xphozah for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis
Ardelyx, Inc. announced the vote of the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for Xphozah for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The CRDAC voted nine to four that the benefits of treatment with Xphozah outweigh its risks for the control of serum phosphorus in adults with CKD on dialysis.
Sharon Moe, M.D., chief of the division of nephrology and hypertension, Indiana University School of Medicine, stated "Xphozah is a novel treatment that provides a clinically meaningful effect on serum phosphate. I am encouraged by the committee's vote. The nephrology community is enthusiastic to have access to this therapy with its novel mechanism of action to help our patients."
The CRDAC review of Xphozah for the control of serum phosphorus in adult patients with CKD on dialysis was based on findings from a comprehensive development program including more than 1,200 patients in three Phase III clinical trials evaluating the safety and efficacy of Xphozah all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY).
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