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Ardelyx to Pursue Formal Dispute Resolution for Tenapanor
Ardelyx maintains that in its comprehensive development program, tenapanor has demonstrated clinical relevance for the control of serum phosphorus in adult
About this update from Ardelyx, Inc.
[{"type":"text","content":"Ardelyx maintains that in its comprehensive development program, tenapanor has demonstrated clinical relevance for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis\n\n\nFREMONT, Calif. and WALTHAM, Mass., Nov. 4, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced the company plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the issuance of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Formal Dispute Resolution is a pathway in the Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. \n\n \n \n \n \n \n \n\n \n\"While we are disappointed that we could not come to a resolution with the Division of Cardiology and Nephrology during the End of Review meeting, the Formal Dispute Resolution process provides an opportunity to raise our scientific disagreement above the division level within CDER,\" said Mike Raab, president and chief executive officer of Ardelyx. \"We believe that this represents the best approach to obtaining approval of tenapanor for the treatment of hyperphosphatemia and bringing this important medicine forward to patients and their treating physicians.\" \n\"Phosphorus management is one of the most challenging aspects of caring for patients on dialysis,\" said Stuart Sprague, DO, FASN, FNKF, chief of the Division of Nephrology and Hypertension at Northshore University Health System, University of Chicago. \"Despite our best efforts with currently available therapies, all of which act via the binding mechanism, nearly 80% of patients are unable to consistently achieve target phosphorus levels established by peer-reviewed global treatment guidelines, in spite of taking up to 10-12 pills per day. Thus, there is a strong need for a novel therapeutic approach, such as that of tenapanor, which blocks gastrointestinal phosphate absorption. The t...