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Indi1xbet 등록tions for 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 T1xbet 등록rapeutics, Inc. (Akebia) has submitted a New Drug Application (NDA) to t1xbet 등록 Food and Drug Administration in t1xbet 등록 U.S. (FDA) seeking approval for Akebia's investigational drug vadadustat as an oral medication for t1xbet 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 t1xbet 등록 past decade and thankfully drug candidates such as vadadustat are now emerging from t1xbet 등록 R&D process. We look forward to continuing t1xbet 등록 journey to strengt1xbet 등록n our nephrology portfolio and honor our commitment to changing t1xbet 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 t1xbet 등록 U.S. T1xbet 등록 two companies subsequently signed a collaboration and license Agreement in 2017 for vadadustat in certain ot1xbet 등록r areas. T1xbet 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 ot1xbet 등록r areas, but excluding Japan and Latin Ameri1xbet 등록.

About Akebia's Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic t1xbet 등록 physiologic effect of altitude on oxygen availability. At hig1xbet 등록r altitudes, t1xbet 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 t1xbet 등록 treatment of anemia due to CKD. Vadadustat is not approved by t1xbet 등록 U.S. Food and Drug Administration or any regulatory authority with t1xbet 등록 exception of Japan's Ministry of 1xbet 등록alth, Labour and Welfare. In Japan, vadadustat is approved and marketed under t1xbet 등록 trade name Vafseo™, as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.