Dispute Resolution: Ardelyx Eyes Tenapanor Resubmission Following Successful Appeal To FDA
Executive Summary
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.
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Japan's latest batch of product approvals includes high-profile Alzheimer's drug Leqembi (lecanemab), along with Alhemo (concizumab) for hemophilia, Phozevel (tenapanor) for hyperphosphatemia and others. Eyes are now on the shape of use guidelines and monitoring requirements for Leqembi, along with how its extended NHI reimbursement pricing process will develop. All going well, it could reach the market by the end of the year.