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Ardelyx’s Tenapanor: FDA Panel To Weigh Treatment Effect Size In Context Of Approved Agents

 
• By Sue Sutter

Agency previously declined to approved tenapanor for the control of serum phosphorous levels in chronic kidney disease patients on dialysis, saying the magnitude of treatment effect on a surrogate endpoint in three clinical trials was less than that observed with approved drugs and of unclear significance.  

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FDA says the small change in serum phosphorous levels with tenapanor raises questions about the drug's clinical benefit. • Source: Shutterstock

The US Food and Drug Administration is asking an advisory committee whether Ardelyx Inc.’s Xphozah (tenapanor) results in a clinically meaningful reduction in serum phosphorous levels in the context of existing hyperphosphatemia treatments that were approved on the basis of the same surrogate endpoint.

A long-running disagreement between the FDA and Ardelyx over the clinical meaningfulness of the reduction in serum phosphorous (s-P) levels with tenapanor will move into the open when the

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