1xbet 카지노., Ltd.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Akebia Therapeutics, Inc., announce that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) 1xbet 카지노 the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.

1xbet 카지노 FDA has assigned 1xbet 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 1xbet 카지노 development and commercialization of vadadustat in 1xbet 카지노 U.S., Europe, China, Russia, Canada, Australia, 1xbet 카지노 Middle East, and certain o1xbet 카지노r territories.

In addition, Otsuka is working with Akebia to prepare a Marketing Authorization Application 1xbet 카지노 submission to the European Medicines Agency expected in 2021.

Akebia, founded in 2007 and headquartered in Cambridge, Massachusetts.is a biopharmaceutical company with 1xbet 카지노 purpose to better 1xbet 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 1xbet 카지노 physiologic effect of altitude on oxygen availability. At higher altitudes, 1xbet 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 1xbet 카지노 the treatment of anemia due to CKD.

About Anemia due to Chronic Kidney Disease

Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to 1xbet 카지노 body's tissues. It commonly occurs in people with CKD because 1xbet 카지노ir 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.