Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments

 
• By Alaric DeArment
  
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While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.

FDA stop sign. Sarah Silbiger/Getty Images
• Source: Sarah Silbiger/Getty Images

First came the delay in its regulatory action date. Now, Ardelyx Inc. has received a Deficiencies Preclude Discussion (DPD) letter from the US Food and Drug Administration stating that the agency has found stumbling blocks in the approval application for tenapanor, its drug to lower serum phosphorus in chronic kidney disease (CKD) patients on dialysis, despite the widespread view that the agency would approve the drug.

Ardelyx said 19 July that it received the letter from the FDA on 13 July, informing the company that the...

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