FDA agency grants appeal of complete response letter for Ardelyx’s phosphate control drug
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Ardelyx Inc. has been granted an appeal to a complete response letter issued last year by the FDA regarding the company’s new drug application for its phosphate absorption inhibitor drug Xphozah.
The decision by the Office of New Drugs (OND) to grant the appeal comes just over a month after members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9-4 in favor of the use of Xphozah as a monotherapy for controlling serum phosphorus levels in adults with chronic kidney disease on dialysis. The CRDAC also voted in favor of using Xphozah (tenapanor) in combination with phosphate binders.
Granting of the appeal allows Ardelyx to resubmit the NDA for Xphozah to the FDA for review, the company said in a press release.
New label
Ardelyx said in the release that OND directed the agency’s Division of Cardiology and Nephrology (DCN) to work with the drugmaker to develop an appropriate label for Xphozah.
“Ardelyx believes that a label could reflect an indication for patients whose hyperphosphatemia is insufficiently managed on binder therapy,” the company said.
As Healio previously reported, Ardelyx had appealed the complete response letter that said Xphozah lacked “clinical significance,” remarks that sent the price of Ardelyx stock down 70%.
"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,” Mike Raab, president and CEO of Ardelyx, said in the release. "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,” Raab said.
Limited options
During the CRDAC meeting, patients spoke of the pill burden and the side effects of using current phosphate binders. Xphozah was administered as a small pill twice a day during clinical trials.
Kevin Martin, MD, professor of internal medicine in the division of nephrology at St. Louis University, said in the release, "This FDA decision is extremely positive for the kidney community and brings us one step closer to having a much-needed novel therapy for the treatment of hyperphosphatemia. The majority of patients are in need of a different approach, as today, despite best efforts with phosphate binders, close to 80% of patients are unable to consistently achieve guideline-established target serum phosphate levels,” Martin said.
Ardelyx said it intends to submit the NDA for Xphozah in the first half of 2023.
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