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Akebia Announces Otsuka's Submission of Initial Marketing Authorization Application to the European Medicines Agency for Vadadustat for the Treatment of Patients with Anemia due to Chronic Kidney Disease
CAMBRIDGE, Mass., Oct. 29, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Oct. 29, 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 Otsuka Pharmaceutical Netherlands B.V. has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia associated with chronic kidney disease (CKD) in adults.\n\n \n \n \n \n \n \n\n \n\"Otsuka's submission of the vadadustat MAA is an important step toward potentially bringing to market a new oral treatment option for patients living with anemia due to CKD. We are pleased to have collaborated on a comprehensive submission,\" said John P. Butler, Chief Executive Officer of Akebia. \"We will continue to work closely with Otsuka through the review process, and to ensure we are well positioned to support a successful commercial launch of vadadustat in Europe, if approved.\"\n\"We are excited to reach this regulatory milestone in collaboration with Akebia, demonstrating our continued commitment to patients with chronic kidney disease,\" said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd. and Otsuka Pharmaceutical Development and Commercialisation Europe GmbH.\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.\nAbout Vadadustat\nVadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) 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. The New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) is under review by the U.S. Food and Drug Administration (FDA). Vadadustat is an investigational new drug and is not approved by the FDA or any regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare (MHLW). In Japan, vadadu...