Akebia Therapeutics, Inc., a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.
“The submission of the vadadustat NDA for the treatment of anemia due to CKD in both adult patients on dialysis and not on dialysis marks a significant milestone not only for Akebia and our partners, but also for patients living with this disease,” stated John P. Butler, Chief Executive Officer of Akebia. “The Akebia team and our collaborator, Otsuka, did an outstanding job preparing this comprehensive submission, which includes substantial data from over 8,000 patients across 36 clinical trials of vadadustat. We look forward to working with the FDA during the review process, and are excited to continue collaborating with our partners to advance vadadustat for the benefit of patients, subject to regulatory approval.”
Based on standard FDA review timelines, the FDA has a 60-day period to determine whether the NDA is complete and acceptable for review. The Company’s NDA submission did not include a Priority Review Voucher.
Otsuka Pharmaceutical Co. Ltd. (Otsuka) is working in close collaboration with Akebia to prepare a Marketing Authorization Application (MAA) for vadadustat for submission to the European Medicines Agency (EMA), expected this year.
About Akebia Therapeutics
Akebia 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.
Vadadustat 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. Vadadustat recently completed its global Phase 3 clinical development program for the treatment of anemia due to CKD. Vadadustat is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority with the exception of Japan’s Ministry of Health, Labour and Welfare (MHLW). In Japan, vadadustat is approved and marketed under the tradename Vafseo™, as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
About Anemia due to Chronic Kidney Disease (CKD)
Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body’s tissues. It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. Anemia due to CKD can have a profound impact on a person’s quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.
Kristen K. Sheppard, Esq.