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Akebia Therapeutics Expects to Resubmit Vadadustat NDA in Third Quarter 2023
Akebia Received Type A Meeting Minutes from the FDA CAMBRIDGE, Mass., Aug. 24, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Akebia Received Type A Meeting Minutes from the FDA \nCAMBRIDGE, Mass., Aug. 24, 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 expects to resubmit its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter of 2023. Upon acceptance of the NDA, Akebia expects the U.S. Food and Drug Administration (FDA) to set a PDUFA date of six months from the date of submission.\n\n \n \n \n \n \n \n\n \nAkebia received Meeting Minutes summarizing the productive and informative discussion held during an End of Dispute Type A meeting with the FDA in July 2023. The minutes reflect Akebia's plan for the NDA resubmission discussed at the meeting.\nVadadustat is currently approved for use in 34 countries. 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 Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.\nForward-Looking StatementStatements in this press release regarding Akebia Therapeutics, Inc.'s (\"Akebia's\") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of...