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Akebia Therapeutics Provides Update on Regulatory Process for Vadadustat
CAMBRIDGE, Mass., March 30, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., March 30, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company met with the U.S. Food and Drug Administration (FDA) Office of New Drugs (OND) deciding authority to discuss Akebia's Formal Dispute Resolution regarding the Complete Response Letter for vadadustat received in March 2022.\n\n \n \n \n \n \n \n\n \nIn February 2023, Akebia received notification from OND that Peter Stein, M.D., Director, OND, assumed responsibility as the deciding authority for the appeal. At the recent meeting, Akebia had a productive discussion with Dr. Stein, who indicated he is continuing internal consultation with experts in OND to complete the review and render a decision.\nAkebia expects to be notified of a response to the appeal within thirty days of Dr. Stein completing his internal discussions, potentially within the second quarter of 2023.\nAbout Akebia TherapeuticsAkebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.\nAbout VadadustatVadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational new drug and is not approved by the U.S. Food and Drug Administration (FDA). On March 29, 2022, the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease (CKD). In November 2022, Akebia submitted a Formal Dispute Resolution Request focused on the favorable balance of the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis. Vadadustat is currently under review by the European Medicines Agency for the treatment of anemia due to CKD in adults. ...