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Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
Application is Supported by Three Positive Phase 3 Clinical Trials for Tenapanor for Hyperphosphatemia, a Condition which affects Approximately 85% of CKD
About this update from Ardelyx, Inc.
[{"type":"text","content":"Application is Supported by Three Positive Phase 3 Clinical Trials for Tenapanor for Hyperphosphatemia, a Condition which affects Approximately 85% of CKD Patients on Dialysis\n\n\nFREMONT, Calif., June 30, 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 the submission of a New Drug Application (NDA) for tenapanor to the U.S. Food and Drug Administration (FDA) 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 submission of our NDA is a significant milestone for Ardelyx, positioning us well to fulfill our promise to offer an innovative first-in-class therapeutic for patients with CKD on dialysis with elevated serum phosphorus,\" said Mike Raab, president and chief executive officer of Ardelyx. \"The clinical results we've generated throughout the development program support the potential for tenapanor to serve as the foundational therapy in the management of hyperphosphatemia based on its unique mechanism of blocking phosphorus at the primary pathway of uptake. In addition to the positive monotherapy results demonstrated in our trials, our NORMALIZE and AMPLIFY trials have demonstrated that with tenapanor alone or with adjunctive use of phosphate binders, a far greater percentage of patients are able to achieve, and maintain, target serum phosphorus levels – a goal which has proven to be unattainable for the majority of patients with currently available treatments. We look forward to working with the FDA through the review process and will continue advancing our preparations for launch.\"\nBased 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.\nThe submission 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-mechanism approach in dialysis patients who had difficult-to-control hyperphosphatemia (≥5.5 mg/dL) despite phosphate binder therapy.\nAbout Ten...