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# FDA Grants Ardelyx’ Xphozah Appeal
- URL: https://www.fdaweb.com/fda-grants-ardelyx-xphozah-appeal/
- Published: 2023-01-03T12:00:00.000Z
- Updated: 2026-09-14T18:10:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153456

The CDER Office of New Drugs (OND) has granted Ardelyx’ appeal of a complete response letter for its NDA for kidney disease drug Xphozah (tenapanor). A company [statement](https://ir.ardelyx.com/news-releases/news-release-details/fda-grants-appeal-ardelyxs-xphozahr-tenapanor?ref=fdaweb.com) says that in granting the appeal, OND directed the Division of Cardiology and Nephrology to work with Ardelyx to develop an appropriate label for the drug.

The company says it believes a label could reflect an indication for patients whose hyperphosphatemia is sufficiently managed on binder therapy. The OND letter also directed Ardelyx to request a meeting with division officials to determine the specific information that will form the basis for resubmitting the NDA. Ardelyx says it will request the meeting as soon as possible to enable it to resubmit the NDA in the first half of the year.

On 11/16/22, the FDA Cardiovascular and Renal Drug Advisory Committee voted 9-4 that the benefits of treatment with Xphozah outweigh its risks for the control of serum phosphorous in adults with chronic kidney disease on dialysis when administered as a monotherapy. The committee also voted 10-2-1 that the benefits of treatment with Xphozah in combination with phosphate binder treatment outweigh its risks.

Ardelyx says that once the NDA is approved, Xphozah would be the first phosphate absorption inhibitor for adults with chronic kidney disease on dialysis with hyperphosphatemia.