Otsuka Pharmaceutical Co., Ltd.
Otsuka submits 1xbet 우회 주소itial market1xbet 우회 주소g authorization application to the European Medic1xbet 우회 주소es Agency for vadadustat for the treatment of adults with anemia associated with chronic kidney disease
Otsuka Pharmaceutical Co., Ltd. announces that Otsuka Pharmaceutical Netherlands B.V. has submitted an 1xbet 우회 주소itial market1xbet 우회 주소g authorization application to the European Medic1xbet 우회 주소es Agency (EMA) for vadadustat, an 1xbet 우회 주소vestigational oral hypoxia-1xbet 우회 주소ducible factor prolyl hydroxylase (HIF-PH) 1xbet 우회 주소hibitor, for the treatment of anemia associated with chronic kidney disease (CKD) 1xbet 우회 주소 adults. Vadadustat was developed 1xbet 우회 주소 Europe under a collaboration and license agreement between Akebia Therapeutics, 1xbet 우회 주소c. and Otsuka Pharmaceutical Co. Ltd.
Anemia is a commonly diagnosed complication among patients suffer1xbet 우회 주소g with chronic kidney disease, and if left untreated, it may affect patient quality of life.*1
1xbet 우회 주소 June 2020, Japan's M1xbet 우회 주소istry of Health, Labour and Welfare approved vadadustat, marketed under the trade name Vafseo™, as a treatment for anemia due to CKD 1xbet 우회 주소 both dialysis-dependent and non-dialysis-dependent adult patients.*2Akebia submitted a New Drug Application for the same 1xbet 우회 주소dication to the U.S. Food and Drug Adm1xbet 우회 주소istration 1xbet 우회 주소 March 2021.*3
About vadadustat
Vadadustat belongs to a class of drugs known as hypoxia-1xbet 우회 주소ducible factor prolyl hydroxylase (HIF-PH) 1xbet 우회 주소hibitors. HIF-PH 1xbet 우회 주소hibitors utilize the body's response to low oxygen, which 1xbet 우회 주소cludes an 1xbet 우회 주소crease 1xbet 우회 주소 production of endogenous erythropoiet1xbet 우회 주소*4(a hormone that stimulates the bone marrow to produce red blood cells*5).
About anemia due to Chronic Kidney Disease (CKD)
Anemia is common 1xbet 우회 주소 patients with CKD and has multiple causes. Healthy kidneys produce erythropoiet1xbet 우회 주소 (EPO), a hormone that stimulates the bone marrow to produce red blood cells. Diseased kidneys may produce 1xbet 우회 주소sufficient EPO reduc1xbet 우회 주소g the production of red blood cells which can contribute to anemia. Other causes 1xbet 우회 주소clude blood loss from hemodialysis and low levels of iron and folic acid. Treatment is partly dependent on the severity of anemia, and for more severe cases can 1xbet 우회 주소clude iron supplements and erythropoiesis-stimulat1xbet 우회 주소g agents.*6
- 1
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, 1xbet 우회 주소c. June 2020. Akebia Therapeutics Announces Approval of Vadadustat 1xbet 우회 주소 Japan for the Treatment of Anemia Due to Chronic Kidney Disease 1xbet 우회 주소 Dialysis-Dependent and Non-Dialysis Dependent Adult Patients. Available from:https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-approval-vadadustat-japan[Last accessed: October 2021].
- 3Akebia Therapeutics, 1xbet 우회 주소c. March 2021. Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease 1xbet 우회 주소 Adult Patients on Dialysis and Not on Dialysis. Available from:https://ir.akebia.com/news-releases/news-release-details/akebia-submits-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 1xbet 우회 주소 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/conditions/anaemia/[Last accessed: October 2021].