Ardelyx: FDA Committee Says Benefits of Xphozah Outweigh Risks in Kidney Disease Patients
17 November 2022 - 1:22AM
Dow Jones News
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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