FDA accepts resubmission of NDA for Xphozah for the control of serum phosphate in adult patients with chronic kidney disease.- Ardelyx.
Ardelyx, Inc. announced that the FDA has accepted its resubmission of a New Drug Application (NDA) for Xphozah (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.
The FDA has determined that the NDA is a class 2 review, which results in a six-month review period from the date of resubmission. The FDA has set a user fee goal date of October 17, 2023.
The company expects Xphozah to be commercially available in the fourth quarter of 2023, as soon as possible following an approval from the FDA. The NDA is supported by a comprehensive development program that included more than 1,200 patients in three Phase III clinical trials evaluating the safety and efficacy of Xphozah, all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY), as well as two additional Phase IV open-label clinical trials (OPTIMIZE and NORMALIZE).
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