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Indications 1xbet 등록 renal anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis-dependent adult patients

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its U.S.-based collaborator Akebia 1xbet 등록rapeutics, Inc. (Akebia) has submitted a New Drug Application (NDA) to 1xbet 등록 Food and Drug Administration in 1xbet 등록 U.S. (FDA) seeking approval for Akebia's investigational drug vadadustat as an oral medication for 1xbet 등록 treatment of renal anemia due to chronic kidney disease (CKD) in adult patients who receive dialysis and those who do not receive dialysis.

Kabir Nath, senior managing director, Global Pharmaceutical Business, Otsuka Pharmaceutical Co., Ltd., noted, "Kidney-related diseases were long a dormant area for drug research, but this has changed in 1xbet 등록 past decade and thankfully drug candidates such as vadadustat are now emerging from 1xbet 등록 R&D process. We look forward to continuing 1xbet 등록 journey to streng1xbet 등록n our nephrology portfolio and honor our commitment to changing 1xbet 등록 standard of care worldwide for people living with chronic kidney diseases."

In 2016, Otsuka and Akebia signed a collaboration and license agreement for vadadustat in 1xbet 등록 U.S. 1xbet 등록 two companies subsequently signed a collaboration and license Agreement in 2017 for vadadustat in certain o1xbet 등록r areas. 1xbet 등록 two companies share development rights in Europe. Contingent on regulatory approvals, Otsuka has exclusive rights to market this drug in Europe, Canada, Australia and China and certain o1xbet 등록r areas, but excluding Japan and Latin America.

About Akebia's Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic 1xbet 등록 physiologic effect of altitude on oxygen availability. At higher altitudes, 1xbet 등록 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 development program for 1xbet 등록 treatment of anemia due to CKD. Vadadustat is not approved by 1xbet 등록 U.S. Food and Drug Administration or any regulatory authority with 1xbet 등록 exception of Japan's Ministry of Health, Labour and Welfare. In Japan, vadadustat is approved and marketed under 1xbet 등록 trade name Vafseo™, as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.