Ardelyx Inc. (NASDAQ:ARDX) has announced that the US FDA has accepted its NDA filing for tenapanor for controlling serum phosphorous in chronic kidney disease patients on dialysis.
NDA clears a pathway for Alderlyx to deliver hypophosphatemia treatment
Mike Raab, CEO of Ardelyx, said that the acceptance of the NDA is good news. It is a huge step towards delivering to the market a completely new approach in the management of hypophosphatemia, an area with a significant unmet medical need. He said that with possible approval in Q2 2021, the company has continued to advance commercial preparations for tenapanor launch. Tenapanor is a non-binder first-in-class therapy targeting the primary phosphorus absorption pathway. Mike said that this is an important period for the company with a focus on doing better for patients.
The FDA has set the Prescription Drug User Fee Act goal date on April 29, 2021. The company supported the NDA with three consecutive third phase trials involving more than 1,000 patients that assessed tenapanor use. The assessment includes two monotherapy trials that included a long term study of controlling serum phosphorous in CKD patients on dialysis and another trail employing a dual mechanism approach in dialysis in patients having challenges in controlling hypophosphatemia despite phosphate binder therapy.
Ardelyx assessing Tenapanor as a monotherapy or combination with sevelamer
Ardelyx discovered and developed tenapanor as a proprietary medicine that is currently under review for controlling serum phosphorus. The mechanism of action of tenapanor is unique, and it acts locally in the gut, inhibiting sodium hydrogen exchanger 3. This leads to conformational epithelial cell junctions change, thus reducing paracelluar uptake of phosphate at the phosphate absorption pathway.
The company is currently carrying NORMALIZE, a PHREEDOM Phase 3 monotherapy extension study designed to assess the ability of tenapanor as a monotherapy or in combination with Sevelamer to attain serum phosphorus at appropriate levels in CKD patients on dialysis. Analyses show that using tenapanor as a monotherapy or combined with sevelamer can produce a significant effect of lowering phosphorous.