By Stephen Nakrosis

Ardelyx, Inc. on Wednesday said a Food and Drug Administration advisory committee voted that the benefits of Xphozah outweighed the risks "for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis."

The Cardiovascular and Renal Drugs Advisory Committee voted 9-4 in favor of Xphozah, or tenapanor, as a monotherapy and voted 10-2 in favor of Xphozah in combination with phosphate binders, the company said.

Ardelyx said the advisory committee's recommendation isn't binding, but added it "will be considered by the Office of New Drugs, Center for Drug Evaluation and Research of the FDA, when making its decision on Ardelyx's second level appeal of the complete response letter received on July 28, 2021, for Xphozah."

The Office of New Drugs is expected to provide a response to the company's appeal within 30 days, Ardelyx said.

The company also said "if approved, Xphozah will be the first and only phosphate absorption inhibitor, reducing serum phosphorus with one pill taken twice daily."

Ardelyx said it will hold a conference call on Nov. 17 at 8 a.m. EST.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

November 16, 2022 19:07 ET (00:07 GMT)

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