- The FDA's Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), has provided an interim response to Ardelyx Inc's ARDX second level of appeal of the Complete Response Letter (CRL) for Xphozah.
- Ardelyx is seeking approval for Xphozah to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
- Xphozah (tenapanor) is an investigational phosphate absorption inhibitor.
- The Company received the letter in July last year.
- The OND noted that additional input from the Cardiovascular and Renal Drug Advisory Committee in general, and specifically from experts, would be valuable in further considering the clinical meaningfulness of the phosphate lowering effect observed in Ardelyx's phase 3 clinical program for Xphozah.
- Also See: Citi, Ladenburg React Positively On Ardelyx's IBS-C Treatment Launch Plans.
- Accordingly, the OND intends to direct the Division of Cardiology and Nephrology to bring the Xphozah marketing application to the Cardiovascular and Renal Drugs Advisory Committee.
- It expects to respond to Ardelyx's appeal within 30 days after the conclusion of the Advisory Committee meeting.
- Price Action: ARDX shares are up 31.80% at $0.99 during the market session on the last check Monday.
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