-=Ardelyx (ARDX) : FDA questions its kidney disorder treatment drug

•  Company receives letter from the FDA identifying deficiencies in the NDA for tenapanor

Ardelyx receives letter from the FDA identifying deficiencies in the NDA for tenapanor that preclude discussions of labeling and post-marketing requirements/commitments at this time  

• Ardelyx received a letter from the FDA on July 13 stating that, as part of its ongoing review of the company's New Drug Application (NDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter stated that the notification does not reflect a final decision on the information under review.
  • Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company submitted an NDA to the FDA in June 2020. In April 2021, the FDA extended the PDUFA date to July 29, 2021, following the submission of additional analyses determined to be a major amendment.
• The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.
  • While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance.
  • The company plans to work with the FDA to learn more about the identified deficiencies and will seek to resolve them as quickly as possible.