Tenapanor for Hyperphosphatemia Approved in Japan - Seite 2

In the U.S., Ardelyx is pursuing approval of tenapanor for the treatment of hyperphosphatemia in adult patients with CKD on dialysis who have had an inadequate response or intolerance to phosphate binder therapy, with the brand name XPHOZAH, and has user fee goal date of October 17, 2023. Pending approval, Ardelyx expects to launch XPHOZAH in the U.S. in the fourth quarter of 2023.

The NDA in Japan was supported by data from four Phase 3 clinical trials, conducted in Japan by Kyowa Kirin in patients with hyperphosphatemia on maintenance dialysis. Across Kyowa Kirin's clinical program, tenapanor demonstrated statistically significant reductions in serum phosphorus levels, both as monotherapy and when added to phosphate binders, for patients whose serum phosphorus levels were poorly controlled on phosphate binders alone. The results of the studies undertaken by Kyowa Kirin suggested that tenapanor may also reduce the medication burden of phosphorus management utilizing marketed phosphate binders in combination with tenapanor or tenapanor alone for treating hyperphosphatemia. In these studies, the safety and tolerability profile for tenapanor was consistent with prior studies in Japan.

Kyowa Kirin made a public announcement regarding the approval, which is available here: https://www.kyowakirin.com/media_center/news_releases/2023/pdf/e202309 ...

About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis who have an inadequate response or intolerance to a phosphate binder therapy, which has completed three successful Phase 3 trials and an additional two Phase 4 open label trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories. For more information, please visit https://ardelyx.com/ and connect with us on Twitter, LinkedIn and Facebook.