FDA agency grants appeal of complete response letter for Ardelyx’s phosphate control drug

Ardelyx Inc. has been granted an appeal to a complete response letter issued last year by the FDA regarding the company’s new drug application for its phosphate absorption inhibitor drug Xphozah.
The decision by the Office of New Drugs (OND) to grant the appeal comes just over a month after members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9-4 in favor of the use of Xphozah as a monotherapy for controlling serum phosphorus levels in adults with chronic kidney disease on dialysis. The CRDAC also voted in favor of using Xphozah (tenapanor) in

Ardelyx Inc. has been granted an appeal to a complete response letter issued last year by the FDA regarding the company’s new drug application for its phosphate absorption inhibitor drug Xphozah.
The decision by the Office of New Drugs (OND) to grant the appeal comes just over a month after members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9-4 in favor of the use of Xphozah as a monotherapy for controlling serum phosphorus levels in adults with chronic kidney disease on dialysis. The CRDAC also voted in favor of using Xphozah (tenapanor) in