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news.Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA).
The Phase III trials were designed to assess the efficacy and safety of Xphozah. Credit: Michal Jarmoluk from Pixabay.
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A first-in-class, phosphate absorption inhibitor, Xphozah will be used to control serum phosphate in adults with chronic kidney disease (CKD) on dialysis and who had an insufficient response or intolerance to a phosphate binder therapy.
It has a new action mechanism and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3).
This reduces the absorption of phosphate via the paracellular pathway, which is the main pathway of phosphate absorption.
Diarrhea was the most common side effect using Xphozah in clinical trials.
The NDA submission was supported by a comprehensive development programme, which included over 1,200 patients in three Phase III clinical trials, PHREEDOM, BLOCK and AMPLIFY, and two additional open-label Phase IV clinical trials, OPTIMIZE and NORMALIZE.
The Phase III trials were designed to assess the efficacy and safety of Xphozah.
The company stated that the all the three Phase III clinical trials met their primary as well as the important secondary endpoints.
Ardelyx expects to receive, an Acknowledgement of Receipt letter, comprising the classification of the resubmission as well as the review goal date, from the regulator in mid-May.
In October last year, the company’s collaboration partner, Kyowa Kirin submitted an NDA to the Japanese Ministry of Health, Labour and Welfare (MHLW) for tenapanor to improve hyperphosphatemia in adult patients with CKD on dialysis.
