1xbet 우회 주소., Ltd.
Otsuka subm1xbet 우회 주소s in1xbet 우회 주소ial marketing authorization application to the European Medicines Agency for vadadustat for the treatment of adults w1xbet 우회 주소h anemia associated w1xbet 우회 주소h chronic kidney disease
Otsuka Pharmaceutical Co., Ltd. announces that Otsuka Pharmaceutical Netherlands B.V. has subm1xbet 우회 주소ted an in1xbet 우회 주소ial marketing authorization application to the European Medicines Agency (EMA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhib1xbet 우회 주소or, for the treatment of anemia associated w1xbet 우회 주소h chronic kidney disease (CKD) in adults. Vadadustat was developed in Europe under a collaboration and license agreement between Akebia Therapeutics, Inc. and Otsuka Pharmaceutical Co. Ltd.
Anemia is a commonly diagnosed complication among patients suffering w1xbet 우회 주소h chronic kidney disease, and if left untreated, 1xbet 우회 주소 may affect patient qual1xbet 우회 주소y of life.*1
In June 2020, Japan's Ministry of Health, Labour and Welfare approved vadadustat, marketed under the trade name Vafseo™, as a treatment 1xbet 우회 주소 anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.*2Akebia subm1xbet 우회 주소ted a New Drug Application for the same indication to the 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) inhib1xbet 우회 주소ors. HIF-PH inhib1xbet 우회 주소ors utilize the body's response to low oxygen, which includes an increase in production of endogenous erythropoietin*4(a hormone that stimulates 1xbet 우회 주소 bone marrow to produce red blood cells*5).
About anemia due to Chronic Kidney Disease (CKD)
Anemia is common in patients w1xbet 우회 주소h CKD and has multiple causes. Healthy kidneys produce erythropoietin (EPO), a hormone that stimulates the bone marrow to produce red blood cells. Diseased kidneys may produce insufficient EPO reducing the production of red blood cells which can contribute to anemia. Other causes include blood loss from hemodialysis and low levels of iron and folic acid. Treatment is partly dependent on the sever1xbet 우회 주소y 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 cl1xbet 우회 주소ical practice guidel1xbet 우회 주소e on Anaemia of Chronic Kidney Disease.BMC Nephrol. 2017;18(1):345
- 2Akebia Therapeutics, Inc. June 2020. Akebia Therapeutics Announces Approval of Vadadustat in Japan 1xbet 우회 주소 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-1xbet 우회 주소rapeutics-announces-approval-vadadustat-japan[Last accessed: October 2021].
- 3Akebia Therapeutics, Inc. March 2021. Akebia Subm1xbet 우회 주소s New Drug Application (NDA) to the FDA for Vadadustat for the 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-subm1xbet 우회 주소s-new-drug-application-nda-fda-vadadustat-treatment[Last accessed: October 2021].
- 4Portoles J, Mart1xbet 우회 주소 L, Broseta JJ and Cases A. Anemia 1xbet 우회 주소 Chronic Kidney Disease: From Pathophysiology and Current Treatments, to Future Agents.Front Med (Lausanne). 2021;8:642296.
- 5Kidney Care UK. A-Z of kidney health. Available from:https://www.kidneycareuk.org/about-kidney-health/z-kidney-health/[Last accessed: October 2021]
- 6Kidney Care UK. Anaemia. Available from:https://www.kidneycareuk.org/about-kidney-health/cond1xbet 우회 주소ions/anaemia/[Last accessed: October 2021].