2014年1月18日讯 --安斯泰来（Astellas）1月17日宣布，降糖药Suglat（25mg，50mg，Ipragliflozin L-Proline）获日本卫生劳动福利部（MHLW）批准，用于2型糖尿病患者的治疗。该药是日本获批用于2型糖尿病治疗的首个SGLT2抑制剂。安斯泰来于2013年3月提交了Suglat的监管申请文件。
Suglat是一种选择性钠葡萄糖同转运蛋白2（SGLT2）抑制剂，由安斯泰来与日本寿制药公司（Kotobuki Pharma）通过合作研究发现，目前正在共同开发。
SGLT是一类膜蛋白，存在于细胞表面，能够将葡萄糖转运至细胞内。SGLT有2种亚型，即SGLT1和SGLT2，分别分布于小肠粘膜和肾小管。SGLT2在近端肾小管葡萄糖再吸收中发挥着关键作用。Suglat通过选择性抑制SGLT2，使肾小管中的葡萄糖不能顺利重吸收进入血液而随尿液排出，从而降低血糖浓度。
Suglat作为单药疗法及与其他药物（6种）联合用药的疗效和安全性，已在一项关键性III期试验及数个临床试验中得到证实。
Approval of Suglat® Tablets, a Selective SGLT2 Inhibitor for Treatment of Type 2 Diabetes, in Japan
TOKYO, January 17, 2014 - Astellas Pharma Inc. (“Astellas”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka) announced today that it has obtained the marketing approval of selective SGLT2 inhibitor Suglat® 25mg and 50mg tablets (generic name Ipragliflozin L-Proline; development code: ASP1941, “Suglat”) for the treatment of type 2 diabetes in Japan. Astellas filed an application for approval in March 2013.
Suglat is a selective SGLT2 (Sodium-Glucose Co-Transporter 2) inhibitor discovered through a research collaboration and is being jointly developed with Kotobuki Pharmaceutical Co., Ltd.. SGLTs are membrane proteins that exist on the cell surface and transfer glucose into cells. SGLT2 is one subtype of SGLTs and plays a key role in the reuptake of glucose in the proximal tubule of the kidneys. Suglat reduces blood glucose levels by inhibiting the reuptake of glucose by selectively inhibiting SGLT2. Suglat is the first SGLT2 inhibitor approved as a treatment for type 2 diabetes in Japan.
The efficacy and safety of Suglat were observed in a Phase III pivotal study in monotherapy and clinical studies used in combination with other hypoglycemic agents (6 types) in Japan..
Astellas will manufacture and sell Suglat and co-promote it with Kotobuki Pharmaceutical Co., Ltd. and MSD K.K..
Astellas expects to provide an additional therapeutic option and further contribute to the treatment of type 2 diabetes by introducing Suglat, an oral hypoglycemic agent with a novel mechanism of action, into the Japanese market.
About Type 2 Diabetes
Diabetes (medically known as diabetes mellitus) is a disorder in which the body has difficulty regulating its blood glucose (sugar) level. There are two major types of diabetes: type 1 and type 2. Type 2 diabetes (formerly called non-insulin-dependent diabetes mellitus or adult-onset diabetes) is a disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. Patients are instructed to increase exercise and diet restrictions, but most require treatment with an anti-diabetic agent to control blood glucose.
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