Ardelyx announces FDA granted appeal for XPHOZAH

Ardelyx announced that the Office of New Drugs, OND, Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, FDA, granted the appeal to the Complete Response Letter, CRL, for the New Drug Application, NDA, for XPHOZAH. In the response letter, OND directed the FDA’s Division of Cardiology and Nephrology to work with Ardelyx to develop an appropriate label. Ardelyx believes that a label could reflect an indication for patients whose hyperphosphatemia is insufficiently managed on binder therapy. In addition, the letter guided Ardelyx to request a meeting with the DCN to determine specific information that will form the basis for resubmission of the NDA for XPHOZAH. Ardelyx will request this meeting as soon as possible to enable the company to resubmit the NDA in the first half of 2023. "By granting the appeal, we believe that OND has sent a powerful message regarding the importance of bringing innovation to the more than 400,000 patients on dialysis who struggle every day, at every meal, to control their phosphorus levels and yet are unable to do so. For more than 60 years, the only choice physicians had for patients has been phosphate binders, and the patients have desperately needed novel mechanism therapies. This is a momentous day for Ardelyx and for all the members of the broader kidney disease community who have supported the development of XPHOZAH over the past ten years," said Mike Raab, president and chief executive officer of Ardelyx. "We appreciate the FDA’s responsiveness to the clear guidance from the Cardiovascular and Renal Drugs Advisory Committee, recognizing the importance of providing a novel therapy for physicians. This could not have been accomplished without the support from members of the kidney community who spoke at the Advisory Committee meeting about the significant unmet patient need and the important role XPHOZAH could play in the hyperphosphatemia treatment paradigm. We look forward to working with the FDA to bring this important medicine to patients and their treating physicians."