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Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
- Vadadustat assigned PDUFA target action date of March 29, 2022 CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq:
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"- Vadadustat assigned PDUFA target action date of March 29, 2022\n\n\nCAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its collaborator, Otsuka Pharmaceutical Co., Ltd. (Otsuka), today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis. \n\n \n \n \n \n \n \n\n \nThe FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022. The FDA also indicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. \n\"The acceptance of our vadadustat NDA filing marks another important milestone for Akebia and Otsuka, as we work to bring a new oral treatment option to patients living with anemia due to CKD,\" said John P. Butler, Chief Executive Officer of Akebia. \"We remain confident in the clarity and quality of our data, and we look forward to working with the FDA during their review of our application. In addition, we continue to collaborate with our partners to ensure we are well positioned to support a successful commercial launch of vadadustat, upon FDA approval.\"\nKabir Nath, board member of Otsuka Pharmaceutical Co., Ltd. and president and CEO of its North American pharmaceutical business noted, \"With Akebia, we are proud to have achieved this milestone in the development of vadadustat. This achievement highlights the teams' ongoing execution as well as our shared commitment to advancing vadadustat with the goal of bringing this novel therapeutic to patients as soon as possible, subject to regulatory approval.\" \nAkebia and Otsuka are collaborating on the development and commercialization of vadadustat in the U.S., Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories. \nIn addition, Otsuka is working with Akebia to prepare a Marketing Authorization Application for vadadustat for submission to the European Medicines Agency expected this year.\nAbout VadadustatVadadustat is an oral hypoxia-inducible factor prolyl hyd...