Ardelyx: FDA Grants Appeal For XPHOZA

(RTTNews) - Ardelyx, Inc. (ARDX) announced the Office of New Drugs, Center for Drug Evaluation and Research of the FDA granted the appeal to the Complete Response Letter for the New Drug Application for XPHOZAH. OND directed the FDA's Division of Cardiology and Nephrology or DCN to work with Ardelyx to develop an appropriate label.

The company said the OND's decision follows a favorable outcome of the November 16, 2022 CRDAC meeting, where the Advisory Committee voted nine to four that the benefits of treatment with XPHOZAH outweigh its risks for the control of serum phosphorus in adults with chronic kidney disease on dialysis when administered as a monotherapy, and voted ten to two, with one abstention, that the benefits of treatment with XPHOZAH in combination with phosphate binder treatment outweigh its risks.

The response letter guided the company to request a meeting with the DCN to determine specific information that will form the basis for resubmission of the NDA for XPHOZAH. Ardelyx said it will request this meeting as soon as possible to enable it to resubmit the NDA in the first half of 2023.

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