FDA Signals Unclear Clinical Benefits Of Ardelyx's Kidney Disease Candidate

The FDA's Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet Wednesday, November 16, to review Ardelyx Inc ARDX Xphozah (tenapanor) to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
FDA staff reviewers raised concerns over unclear benefits of Ardelyx's drug for kidney disease patients, but the company's shares are up on expectations over a possible approval.
The FDA's staff reviewers said that "the magnitude of treatment effect appears less than that observed with approved drugs" in the released briefing documents.
The review team concludes it expects that tenapanor's average treatment effect on s-P, when used in patients who tolerate and remain on therapy, is about 0.7 mg/dL. The magnitude of the treatment effect appears to be less than that observed with approved agents (~1.5 to 2.2 mg/dL).
In July last year, the FDA issued a Complete Response Letter to Ardelyx's marketing application seeking approval for tenapanor.
Additionally, the FDA asked Ardelyx to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect.
Price Action: ARDX shares are up 4.74% at $1.3093 on the last check Monday.

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