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

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