Xphozah is a single tablet, twice daily inhibitor with a differentiated mechanism of action that blocks phosphate absorption through its primary pathway
Ardelyx's Xphozah has secured FDA approval. (Credit: Lakshmiraman Oza from Pixabay)
Ardelyx said the US Food and Drug Administration (FDA) has approved Xphozah (tenapanor), a phosphate absorption inhibitor, to lower serum phosphorus in certain adults with chronic kidney disease (CKD).
The FDA has approved Xphozah for CKD patients on dialysis as add-on therapy who showed little response to phosphate binders or who cannot tolerate any dose of phosphate binder therapy.
Xphozah is a single tablet, twice daily inhibitor with a differentiated mechanism of action that prevents phosphate absorption through its primary pathway.
In November last year, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted in favour of Xphozah.
Its approval is based on a comprehensive development programme, including a diverse population of over 1,000 patients across three Phase 3 clinical studies.
The late-stage trials, PHREEDOM, BLOCK, and AMPLIFY, assessed the safety and efficacy of Xphozah, as monotherapy and in combination with phosphate binder therapy.
According to the results, the twice daily inhibitor met the primary and key secondary endpoints of all the studies. The phosphate absorption inhibitor demonstrated significantly reduced elevated serum phosphorus in patients who were administered with maintenance haemodialysis.
The only adverse reaction reported in at least 5% of Xphozah-treated patients with CKD on dialysis across trials was diarrhoea.
Ardelyx president and CEO Mike Raab said: “Since the founding of the company in 2007, we have been steadfast in our commitment to the kidney community, and today’s approval reinforces the compelling clinical profile and potential benefit that Xphozah may provide for so many patients.
“This therapy was born in our labs in 2008, and to now see it becoming available for patients is truly a testament to the dedication, outstanding execution, and sense of mission of the Ardelyx team.
“This approval is also a tribute to the patients, families, physicians and clinical trial personnel who participated in the development of Xphozah.
“There is a high level of anticipation and enthusiasm for the launch of Xphozah from the kidney community, and our world-class team will enter the marketplace well positioned with a first-in-class product.”
Ardelyx also concluded two open-label trials OPTIMIZE and NORMALIZE to assess various options for incorporating Xphozah into clinical practice.