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
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.
By AP News
Published - Nov 16, 2022, 06:48 PM ET
Last Updated - Apr 03, 2024, 08:38 AM EDT
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 Drugs is expected to provide a response to Ardelyx's appeal within thirty (30) days
If approved, XPHOZAH will be the first and only phosphate absorption inhibitor, reducing serum phosphorus with one pill taken twice daily
Conference call to be held tomorrow, November 17, 2022, at 8:00 AM ET
