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Akebia Therapeutics Completed Type A Meeting with the FDA and Expects to Resubmit Vadadustat NDA in Third Quarter 2023
CAMBRIDGE, Mass., July 18, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., July 18, 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 Akebia completed an End of Dispute Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss Akebia's forthcoming resubmission of its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis.\n\n \n \n \n \n \n \n\n \n\"We're pleased to report we recently met with the FDA to align on the content of our NDA resubmission for vadadustat,\" said John P. Butler, Chief Executive Officer of Akebia. \"The meeting was informative and productive, and we're eager to advance the U.S. regulatory process and potentially bring a new oral treatment to dialysis patients with anemia due to CKD.\" \nAkebia expects to receive the FDA's meeting minutes by mid-August and plans to resubmit its NDA for vadadustat by the end of the third quarter of 2023. Upon acceptance of the NDA, Akebia expects the FDA to set a PDUFA date of six months from the date of submission.\nVadadustat is currently approved for use in 34 countries, it was most recently approved by the Swiss Agency for Therapeutic Products (Swissmedic) in June 2023. Vafseo® (vadadustat) is marketed in Japan by Mitsubishi Tanabe Pharma Corporation. \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 not approved by the U.S. Food and Drug Administration (FDA). Vadadustat is approved in Europe for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis. In J...