Posted by Michael Wonder on 29 Jul 2021
Ardelyx receives complete response letter from U.S. FDA for new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
29 July 2021 - Ardelyx today announced that it has received a complete response letter from the U.S. FDA regarding the company's new drug application for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis.
According to the complete response letter. while the FDA agrees that "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis," they characterise the magnitude of the treatment effect as "small and of unclear clinical significance."
