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Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis
The Advisory Committee voted 9:4 in favor of XPHOZAH as a monotherapy and 10:2 in favor of XPHOZAH in combination with phosphate binders The Office of New
About this update from Ardelyx, Inc.
[{"type":"text","content":"The Advisory Committee voted 9:4 in favor of XPHOZAH as a monotherapy and 10:2 in favor of XPHOZAH in combination with phosphate binders\nThe Office of New Drugs is expected to provide a response to Ardelyx's appeal within thirty (30) days \nIf approved, XPHOZAH will be the first and only phosphate absorption inhibitor, reducing serum phosphorus with one pill taken twice daily \nConference call to be held tomorrow, November 17, 2022, at 8:00 AM ET\nWALTHAM, Mass., Nov. 16, 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 the vote of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The CRDAC voted nine to four that the benefits of treatment with XPHOZAH outweigh its risks for the control of serum phosphorus in adults with CKD on dialysis when administered as a monotherapy and voted ten to two, with one abstention, that the benefits of treatment with XPHOZAH in combination with phosphate binder treatment outweigh its risks.\n\n \n \n \n \n \n \n\n \n\"Today's vote by the CRDAC is a promising development for the chronic kidney disease community, as patients continue to struggle to control serum phosphorus levels despite use of currently available therapies, which are all limited to the phosphate binder class,\" said Mike Raab, president and chief executive officer of Ardelyx. \"We are confident that the data from three Phase 3 clinical trials involving more than 1,200 patients support the approval of XPHOZAH in the U.S. for the control of serum phosphorus in adult patients with CKD on dialysis. We want to thank the patients, physicians and the advocacy community who shared their valuable insights today and throughout the development program. We are hopeful following today's discussion that the data, the opinion of the advisory committee, the needs of patients, and the compelling voice of the broader nephrology community will be reflected in the FDA's decision on our appeal.\"\nSharon Moe, M.D., chief of the division of nephrology and hypertension, Indiana University School of...