Ardelyx kidney disease drug Xphozah secures US nod on second try

2023-10-18

上市批准临床3期临床结果ASH会议

Ardelyx announced Tuesday that it obtained FDA approval for Xphozah (tenapanor) to reduce serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The decision marks a comeback for the drug, which had previously been rejected by US regulators in 2021 after describing its effect as "small and of unclear clinical significance."

CEO Mike Raab called the approval "an important milestone…as it represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus." The NHE3 sodium transport inhibitor NHE3 sodium transport inhibitor was approved in the US in 2019 under the name Ibsrela for the treatment of irritable bowel syndrome with constipation.

Xphozah, which Raab said is expected to be available in November, is specifically indicated as an add-on for those who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. The approval was based on data from the Phase III PHREEDOM, BLOCK and AMPLIFY trials involving more than 1000 patients. The studies, which evaluated the drug as monotherapy and in combination with phosphate binder therapy, all met their primary and key secondary endpoints, significantly reducing elevated serum phosphorus levels in patients receiving maintenance haemodialysis.

Earlier CRL

The 2021 complete response letter (CRL) had prompted Ardelyx to lay off 65% of its workforce, although the company also pursued multiple appeals of the FDA's decision. Late last year, a panel of external FDA advisors voted that the benefits of Xphozah outweigh its risks, with the agency ultimately granting Ardelyx's appeal. The company refiled its marketing application for Xphozah this past April.

Ardelyx is slated to present updated results on the drug for hyperphosphataemia at an American Society of Nephrology (ASN) meeting early next month. Company shares jumped in late September after Japanese regulators approved tenapanor, under the name Phozevel, for hyperphosphatemia in adults with CKD on dialysis. Ardelyx is partnered on the drug with Kyowa Kirin, with the latter having exclusive rights to develop and commercialise the product for cardiorenal diseases, including hyperphosphataemia, in Japan.

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