Ibsrela filed with FDA for hyperphosphatemia in adult patients with chronic kidney disease on dialysis.- Ardelyx

Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic kidney disease (CKD) on dialysis. Based on standard FDA review timelines, the company expects to receive notification from the FDA on the acceptance of the filing for substantive review in late August 2020.

The submission is supported by three successful Phase III trials involving over 1,000 patients that evaluated the use of tenapanor, which included: two monotherapy trials, including a long-term study, to control serum phosphorus in patients with CKD on dialysis, and one trial using a dual-mechanism approach in dialysis patients who had difficult-to-control hyperphosphatemia (at least 5.5 mg/dL) despite phosphate binder therapy.