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首页 » 产品 » 协和发酵麒麟向日本MHLW提交重组人抗凝血酶KW-3357上市许可申请

协和发酵麒麟向日本MHLW提交重组人抗凝血酶KW-3357上市许可申请

来源:生物谷 2014-08-04 19:05

2014年8月4日讯 /生物谷BIOON/ --日本协和发酵麒麟(Kyowa Hakko Kirin)8月1日宣布,已向日本劳动卫生福利部(MHLW)提交了重组人抗凝血酶(AT)(代号:KW-3357)的上市许可申请(MAA),寻求批准用于先天性AT III缺乏症(CAD)导致的易栓症(Thrombophilia)以及伴有AT III水平降低的弥散性血管内凝血(DIC)的治疗。

协和发酵麒麟开展了下述III期临床试验,确定了KW-3357的疗效和安全性,并根据这些数据提交了该药的上市许可申请:

(1)一项开放标签、平行组、随机III期研究,在感染相关的DIC患者中开展,将KW-3357与血浆来源的AT(pAT)进行了对比。数据表明,KW-3357与pTA在主要终点DIC恢复率及其他疗效终点及安全性方面,均取得了相似的结果;

(2)一项开放标签III期研究,在满足日本JAAM诊断标准或JMHW诊断标准的DIC患者中开展,该项研究确定了KW-3357联合肝素/肝素类似物用于DIC治疗的疗效和安全性。

KW-3357是一种重组的抗凝血酶(AT),与源于人类血浆的抗凝血酶(pAT)具有相同的氨基酸序列及相似的糖链性质。AT通过与参与血液凝固的蛋白酶形成复合物,抑制凝结剂的作用。由于KW-3357是一种重组AT制剂,因此可避免由血液引发的感染风险。(生物谷Bioon.com)

英文原文:Kyowa Hakko Kirin Submits Application for Approval in Japan for KW-3357

Tokyo, Japan, August 1, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare (MHLW) for recombinant human antithrombin (AT) preparation (code name: KW-3357) which is developed for thrombophilia due to congenital AT III deficiency (CAD) and disseminated intravascular coagulation (DIC) accompanied by a decrease in AT III.

Kyowa Hakko Kirin conducted the phase 3 studies described below in order to confirm the safety and efficacy of KW-3357 in Japan and filed a marketing approval application for the preparation based on the results of those phase 3 studies.

1) The open-label, parallel-group, randomized study of KW-3357 versus plasma-derived AT (pAT) in patient with DIC associated with infections indicated that KW-3357 showed the similar results as pAT in recovery rate from DIC on Day 6 as the primary endpoint, other endpoints for efficacy and the safety profile.

2) Effectiveness and safety of KW-3357 were confirmed in the open-label studies of KW-3357 with heparins/heparinoids in patients with DIC by The Japanese Association for Acute Medicine (JAAM) diagnostic criteria or The Japanese Ministry of Health and Welfare (JMHW) diagnostic criteria.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About Antithrombin (AT)

Antithrombin (AT) is a component of blood that inhibits blood coagulation. It is a single-chain glycoprotein with a molecular weight of approximately 60,000. The indications for the native form of AT preparation currently on the market are "thrombophilia due to congenital AT III deficiency" and disseminated intravascular coagulation accompanied by a decrease in AT III.

About KW-3357

KW-3357 is a preparation containing a recombinant AT that has the identical amino acid sequence of human plasma derived AT and the similar sugar chain profile. AT inhibits coagulant action by forming a complex with the protease involved in blood coagulation. Since KW-3357 is a recombinant AT preparation, it is expected that the infection risk resulting from human blood will be avoided.

About Congenital Antithrombin Deficiency (CAD)

CAD is a genetic disorder characterized by iterative thrombosis. Continued AT deficiency results in a decrease in anticoagulant activity, and minor factors that normally would not lead to thrombus formation can result in thrombosis.

About Disseminated Intravascular Coagulation (DIC)

Disseminated Intravascular Coagulation may be observed as a disorder that accompanies cancer, serious infections such as septicemia, leukemia, malignant lymphoma, placental abruption and so forth. When a person has DIC, blood clots are formed more easily in the capillaries around the body and results in clots that obstruct blood circulation in organs such as the kidneys, liver, and brain, which then causes disorders in the affected organs. If many clots form, platelets and coagulant factors are spent not to form new clots for hemostasis. The reactions to dissolve clots get to be enhanced for the multiple clots at the same time. These things result in bleeding.

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