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FDA panel backs Ardelyx CKD drug, despite agency concerns

November 17, 2022

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The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted yesterday by nine to four that the benefits of Xphozah (tenapanor) outweigh its risks when given as a monotherapy to treat high phosphate levels in the blood in adults with CDK who are on dialysis.

The panel also voted by 10 to two, with one abstention, that it is safe to use in combination with conventional phosphate binder drugs, the only approved therapy for hyperphosphataemia. Xphozah works in a different way, blocking absorption of phosphate in the gut.

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