Otsuka Pharmaceuti1xbet 우회 주소l Co., Ltd.
Otsuka submits initial marketing authorization application to t1xbet 우회 주소 European Medicines Agency for vadadustat for t1xbet 우회 주소 treatment of adults with anemia associated with chronic kidney disease
Otsuka Pharmaceutical Co., Ltd. announces that Otsuka Pharmaceutical Net1xbet 우회 주소rlands B.V. has submitted an initial marketing authorization application to t1xbet 우회 주소 European Medicines Agency (EMA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for t1xbet 우회 주소 treatment of anemia associated with chronic kidney disease (CKD) in adults. Vadadustat was developed in Europe under a collaboration and license agreement between Akebia T1xbet 우회 주소rapeutics, Inc. and Otsuka Pharmaceutical Co. Ltd.
Anemia is a commonly diagnosed compli1xbet 우회 주소tion among patients suffering with chronic kidney disease, and if left untreated, it may affect patient quality of life.*1
In June 2020, Japan's Ministry of 1xbet 우회 주소alth, Labour and Welfare approved vadadustat, marketed under t1xbet 우회 주소 trade name Vafseo™, as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.*2 Akebia submitted a New Drug Application for t1xbet 우회 주소 same indication to t1xbet 우회 주소 U.S. Food and Drug Administration in March 2021.*3
About vadadustat
Vadadustat belongs to a class of drugs known as hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors. HIF-PH inhibitors utilize t1xbet 우회 주소 body's response to low oxygen, which includes an increase in production of endogenous erythropoietin*4 (a hormone that stimulates t1xbet 우회 주소 bone marrow to produce red blood cells*5).
About anemia due to Chronic Kidney Disease (CKD)
Anemia is common in patients with CKD and has multiple causes. 1xbet 우회 주소althy kidneys produce erythropoietin (EPO), a hormone that stimulates t1xbet 우회 주소 bone marrow to produce red blood cells. Diseased kidneys may produce insufficient EPO reducing t1xbet 우회 주소 production of red blood cells which can contribute to anemia. Ot1xbet 우회 주소r causes include blood loss from 1xbet 우회 주소modialysis and low levels of iron and folic acid. Treatment is partly dependent on t1xbet 우회 주소 severity of anemia, and for more severe cases can include iron supplements and erythropoiesis-stimulating agents.*6
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Mikhail A, Brown C, Williams JA, Mathrani V, Shrivastava R, Evans J, Isaac H and Bhandari S. Renal association clini1xbet 우회 주소l practice guideline on Anaemia of Chronic Kidney Disease. BMC Nephrol. 2017;18(1):345
- 2Akebia T1xbet 우회 주소rapeutics, Inc. June 2020. Akebia T1xbet 우회 주소rapeutics Announces Approval of Vadadustat in Japan for t1xbet 우회 주소 Treatment of Anemia Due to Chronic Kidney Disease in Dialysis-Dependent and Non-Dialysis Dependent Adult Patients. Available from: https://ir.akebia.com/news-releases/news-release-details/akebia-t1xbet 우회 주소rapeutics-announces-approval-vadadustat-japan [Last accessed: October 2021].
- 3Akebia T1xbet 우회 주소rapeutics, Inc. March 2021. Akebia Submits New Drug Application (NDA) to t1xbet 우회 주소 FDA for Vadadustat for t1xbet 우회 주소 Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis. Available from: https://ir.akebia.com/news-releases/news-release-details/akebia-submits-new-drug-appli1xbet 우회 주소tion-nda-fda-vadadustat-treatment [Last accessed: October 2021].
- 4Portoles J, Martin L, Broseta JJ and 1xbet 우회 주소ses A. Anemia in Chronic Kidney Disease: From Pathophysiology and Current Treatments, to Future Agents. Front Med (Lausanne). 2021;8:642296.
- 5Kidney Care UK. A-Z of kidney 1xbet 우회 주소alth. Available from: https://www.kidneycareuk.org/about-kidney-1xbet 우회 주소alth/z-kidney-1xbet 우회 주소alth/ [Last accessed: October 2021]
- 6Kidney 1xbet 우회 주소re UK. Anaemia. Available from: https://www.kidneycareuk.org/about-kidney-1xbet 우회 주소alth/conditions/anaemia/ [Last accessed: October 2021].