- The FDA's Cardiovascular and Renal Drugs Advisory Committee voted in favor of Ardelyx Inc's ARDX Xphozah (tenapanor) for controlling serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
- The adcomm voted 9:4 in favor of Xphozah as monotherapy and 10:2 in favor of Xphozah in combination with phosphate binders.
- If approved, Xphozah will be the first and only phosphate absorption inhibitor, reducing serum phosphorus with one pill taken twice daily.
- The review of Xphozah was based on findings from a comprehensive development program including more than 1,200 patients in three Phase 3 trials, all of which met their primary and key secondary endpoints.
- In FDA briefing documents, the staff reviewers raised concerns over unclear benefits of Ardelyx's drug for kidney disease patients. They said that "the magnitude of treatment effect appears less than that observed with approved drugs.
- In July last year, the FDA issued a Complete Response Letter to Ardelyx's marketing application seeking approval for tenapanor.
- Price Action: ARDX shares are up 67.20% at $2.04 during the premarket session on the last check Thursday.
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