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Ardelyx Announces FDA Advisory Committee Meeting to Review XPHOZAH® NDA Tentatively Scheduled for November 16, 2022
WALTHAM, Mass. , June 21, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and
About this update from Ardelyx, Inc.
[{"type":"text","content":"WALTHAM, Mass. , June 21, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has informed the company that a meeting of the Cardiovascular and Renal Drugs Advisory Committee (Advisory Committee) is tentatively scheduled for November 16, 2022. The Advisory Committee will discuss the company's New Drug Application (NDA) for XPHOZAH 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 \nAs part of its response to Ardelyx's appeal of the Complete Response Letter received on July 28, 2021, the FDA's Office of New Drugs (OND) stated that additional input from an Advisory Committee, including the addition of input from expert clinicians who care for patients on dialysis, would be valuable in further considering the clinical meaningfulness of the phosphate lowering effect observed in Ardelyx's Phase 3 clinical program in order to reach a decision on the company's formal dispute resolution request. A response from the OND to Ardelyx's appeal is expected within thirty calendar days after the conclusion of the Advisory Committee meeting.\nAbout XPHOZAH (tenapanor) for HyperphosphatemiaXPHOZAH (tenapanor), discovered and developed by Ardelyx, in an investigational first-in-class phosphate absorption inhibitor (PAI). XPHOZAH, with its unique blocking mechanism of action, acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. This novel blocking mechanism enables a one 30 mg tablet BID dosing regimen. The most common side effect with tenapanor in clinical trials was diarrhea.\nAbout Ardelyx, Inc.Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx's first approved product, IBSRELA® (tenapanor) is available in the United States. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 tr...