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Dispute Resolution: Ardelyx Eyes Tenapanor Resubmission Following Successful Appeal To FDA

 
• By Sue Sutter

Office of New Drugs grants company’s appeal of complete response letter for tenapanor in dialysis patients, marking a rare sponsor victory through the agency’s formal dispute resolution process; new drug application resubmission is targeted for first half of 2023.

Chess pieces
Ardelyx prevailed in its appeal of a complete response letter. • Source: Shutterstock

A rare sponsor victory on an appeal of a complete response letter for Ardelyx Inc.’s phosphate absorption inhibitor Xphozah (tenapanor) could embolden other sponsors to pursue dispute resolution when a US Food and Drug Administration review division concludes a drug is not approvable based upon currently available evidence.

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