The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.
The regulatory agency has determined that the NDA is a class 2 review, which leads to a six-month review period from the date of resubmission.
It has set a user fee goal date of 17 October this year.
The biopharmaceutical company expects XPHOZAH to be commercially available in Q4 2023 after an approval from the regulatory body.
Ardelyx president and CEO Mike Raab said: “The acceptance of our NDA is a significant milestone in our journey to bring XPHOZAH to patients. We are excited about the prospect of working collaboratively with the FDA to finalise this review over the next few months.
“We are now in full preparation mode and intend to launch XPHOZAH to the physician and patient communities who have patiently waited for access to this novel therapy as soon as possible after we receive an approval notification from the FDA, finally bringing this much-needed treatment to patients.”
The NDA is backed by a thorough development programme that included over 1,200 patients in three Phase 3 clinical trials – PHREEDOM, BLOCK and AMPLIFY – assessing the safety and efficacy of XPHOZAH, all of which met their primary and important secondary endpoints, as well as two further Phase 4 open-label clinical trials – OPTIMIZE and NORMALIZE.
Discovered and developed by Ardelyx, XPHOZAH is a first-in-class, phosphate absorption inhibitor that has a new mechanism of action and acts locally in the gut to hinder the sodium hydrogen exchanger 3 (NHE3), thereby lowering phosphate absorption through the paracellular pathway, which is the main pathway of phosphate absorption.
This new blocking mechanism allows a one 30mg tablet twice daily dosing regimen. Diarrhea was the most common side effect with XPHOZAH.