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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.  

Small size
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.

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