FDA approves new drug application for phosphorus drug
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Ardelyx Inc. recently announced the FDA has accepted its new drug application of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis.
“The acceptance of our NDA is extremely exciting as it represents the next critical step towards bringing to market a completely new approach to the management of hyperphosphatemia, an area where a significant unmet need exists,” Mike Raab, president and CEO of Ardelyx, said in a press release. “With potential approval in the second quarter of 2021, we continue to advance commercial preparations for the launch of tenapanor, a first-in-class, non-binder therapy that targets the primary pathway of phosphorus absorption.”
According to the release, the FDA has set a Prescription Drug User Fee Act goal date of April 29, 2021.
“I look forward to the prospect of having a novel approach to treating hyperphosphatemia, a condition known to be associated with higher morbidity and mortality in patients with chronic kidney disease on dialysis,” Kam Kalantar-Zadeh, MD, chief of the division of nephrology and hypertension and kidney transplantation at the University of California Irvine School of Medicine, said. “I believe innovations that enable us to block phosphorus via the primary pathway of absorption will help us more consistently and effectively manage phosphorus, so we can do better for our patients.”
The company completed three phase 3 trials (involving more than 1,000 patients) that evaluated the use of tenapanor, an oral medication, to control serum phosphorus in patients with CKD on dialysis and one trial using a dual-mechanism approach in patients on dialysis who had difficult-to-control hyperphosphatemia (5.5 mg/dL) despite phosphate binder therapy, according to the release.
Tenapanor acts locally in the gut to inhibit the sodium hydrogen exchanger 3, resulting in a “conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption,” according to the release.
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