US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain
Executive Summary
Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.
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Dispute Resolution: Ardelyx Eyes Tenapanor Resubmission Following Successful Appeal To FDA
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.
Dispute Resolved? Ardelyx’s Tenapanor Gets US FDA Panel Nod For Dialysis Patients
Tenapanor could be an option for dialysis patients who cannot tolerate phosphate binder therapy or who need more help in reaching their serum phosphorous targets, advisory committee members said; Office of New Drugs director Peter Stein is expected to rule on Ardelyx’s appeal of a complete response letter within 30 days.
Ardelyx’s Tenapanor: FDA Panel To Weigh Treatment Effect Size In Context Of Approved Agents
Agency previously declined to approved tenapanor for the control of serum phosphorous levels in chronic kidney disease patients on dialysis, saying the magnitude of treatment effect on a surrogate endpoint in three clinical trials was less than that observed with approved drugs and of unclear significance.