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Ardelyx Announces FDA Acceptance for Filing of its New Drug Application of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
NDA Supported by Data from Expansive Clinical Development Program Demonstrating Tenapanor's use as Foundational Therapy PDUFA Goal Date - April 29, 2021
About this update from Ardelyx, Inc.
[{"type":"text","content":"NDA Supported by Data from Expansive Clinical Development Program Demonstrating Tenapanor's use as Foundational Therapy\n PDUFA Goal Date - April 29, 2021\n\n\nFREMONT, Calif., Sept. 15, 2020 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. \n\n \n \n \n \n \n \n\n \n\"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,\" said Mike Raab, president, and chief executive officer of Ardelyx. \"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. This is a special time for the Ardelyx team as we have a clear mission – that we can and should do better for patients. We believe that with tenapanor, we have discovered and developed a therapy that will truly advance care for patients on dialysis.\" \nThe FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of April 29, 2021. \n\"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,\" said Dr. Kam Kalantar-Zadeh, Chief, Division of Nephrology and Hypertension and Kidney Transplantation, University of California, Irvine, School of Medicine. \"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.\" \nThe NDA is supported by three successful Phase 3 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-mec...