The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) of tenapanor (Ardelyx) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
Tenapanor, a first-in-class oral medication, works by blocking sodium/hydrogen exchanger 3 (NHE3) in the gastrointestinal (GI) tract, reducing the absorption of dietary sodium resulting in increased protons within the cells. The increase in protons causes a selective reduction in phosphate uptake by tightening junctions that regulate phosphate absorption in the GI tract. Tenapanor is minimally absorbed and is designed to work only within the GI tract, reducing the potential for side effects.
The NDA is supported by three phase 3 trials that evaluated the effects of tenapanor in over 1000 patients. Findings from these trials showed that treatment with tenapanor met the primary end point, achieving a statistically significant reduction in serum phosphorus levels. As for safety, tenapanor was well tolerated with the most common self-reported adverse event being loose stools/diarrhea.
A Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2021 has been set for this application.
In 2019, tenapanor received FDA approval for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
For more information visit ardelyx.com.
Ardelyx announces FDA acceptance for filing of its New Drug Application of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. https://www.prnewswire.com/news-releases/ardelyx-announces-fda-acceptance-for-filing-of-its-new-drug-application-of-tenapanor-for-the-control-of-serum-phosphorus-in-adult-patients-with-ckd-on-dialysis-301130860.html. Accessed September 16, 2020.