FDA extends the PDUFA date for tenapanor for the control of serum phosphorus in patients with CKD on dialysis.-Ardelyx, Inc.

Ardelyx, Inc. announced that the Prescription Drug User Fee Act (PDUFA) date for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis has been extended by three months. Following constructive labeling discussions with the FDA that began in early April, the agency made a recent information request that required the company to submit additional analyses to help the agency better understand the clinical data in light of tenapanor's novel mechanism of action as compared to approved therapies. In response, the company submitted the requested analyses which constitute a major amendment to the New Drug Application (NDA), resulting in an extension of the PDUFA date by three months to July 29, 2021.