Ardelyx Appeal of Xphozah Denial Granted by FDA

By Dean Seal

Ardelyx Inc. said Thursday that the U.S. Food and Drug Administration has granted an appeal of its earlier rejection of the company's Xphozah drug candidate.

The Waltham, Mass.-based biopharmaceutical company said the FDA has directed its Division of Cardiology and Nephrology to work with Ardelyx on the development of an appropriate label for Xphozah, a drug used to control of serum phosphorus in adults with chronic kidney disease who are on dialysis.

The FDA has also advised Ardelyx to request a meeting with the Division of Cardiology and Nephrology to determine what specific information the company will need to furnish in its resubmission of a New Drug Application for Xphozah.

The agency rejected Ardelyx's previous application last year, but an advisory committee for the FDA voted in mid-November that the benefits of Xphozah outweigh its risks, paving the way for an appeal.

Ardelyx said it plans to resubmit the application in the first half of next year.

The company's shares rose 9.1%, to $2.74, in premarket trading.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

December 29, 2022 08:10 ET (13:10 GMT)

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