Ardelyx announced the U.S. Food and Drug Administration’s Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), provided an interim response to the company’s second level of appeal for tenapanor.
The OND indicated that more input from the Cardiovascular and Renal Drug Advisory Committee and other clinical experts would be of use in further evaluating the clinical meaningfulness of the phosphate lowering effect the company reported in its Phase III program for the drug, which goes by the trade name Xphozah for this indication.
As such, the OND plans to direct the Division of Cardiology and Nephrology to bring Ardelyx’s New Drug Application (NDA) for tenapanor before the Cardiovascular and Renal Drugs Advisory Committee. In addition, it will require a response to the company’s appeal within 30 days after the conclusion of the adcomm meeting.
In July 2021, the FDA issued Ardelyx a Complete Response Letter (CRL) for its tenapanor, which it is developing for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Then in November 2021, the company submitted a Formal Dispute Resolution Request (FDRR) to appeal the CRL. In July 2021, the FDA issued Ardelyx a Complete Response Letter (CRL) for its tenapanor, which it is developing for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Then in November 2021, the company submitted a Formal Dispute Resolution Request (FDRR) to appeal the CRL. Read more here.