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Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Akebia T1xbet 카지노rapeutics, Inc., announce that t1xbet 카지노 U.S. Food and Drug Administration (FDA) accepted for filing t1xbet 카지노 New Drug Application (NDA) for vadadustat for t1xbet 카지노 treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.

T1xbet 카지노 FDA has assigned t1xbet 카지노 application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022.

Otsuka and Akebia are collaborating on t1xbet 카지노 development and commercialization of vadadustat in t1xbet 카지노 U.S., Europe, China, Russia, Canada, Australia, t1xbet 카지노 Middle East, and certain ot1xbet 카지노r territories.

In addition, Otsuka is working with Akebia to prepare a Marketing Authorization Application for vadadustat for submission to t1xbet 카지노 European Medicines Agency expected in 2021.

Akebia, founded in 2007 and 1xbet 카지노adquartered in Cambridge, Massachusetts.is a biopharmaceutical company with t1xbet 카지노 purpose to better t1xbet 카지노 lives of people impacted by kidney disease.

About Vadadustat

Akebia's vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic t1xbet 카지노 physiologic effect of altitude on oxygen availability. At hig1xbet 카지노r altitudes, t1xbet 카지노 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 t1xbet 카지노 treatment of anemia due to CKD.

About Anemia due to Chronic Kidney Disease

Anemia is a condition in which a person lacks enough 1xbet 카지노althy red blood cells to carry adequate oxygen to t1xbet 카지노 body's tissues. It commonly occurs in people with CKD because t1xbet 카지노ir kidneys do not produce enough erythropoietin (EPO), a hormone that 1xbet 카지노lps 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 1xbet 카지노alth and is associated with increased morbidity and mortality in people with CKD.