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全球首个每周一次口服降糖药曲格列汀trelagliptin获批!
2015-3-29
来源:生物谷  作者:admin  发布时间:2015-03-27
内容摘要:日本制药巨头武田(Takeda)近日宣布,糖尿病新药Zafatek(trelagliptin succinate,曲格列汀琥珀酸盐)获日本卫生劳动福利部(MHLW)批准,用于2型糖尿病的治疗。此次批准,标志着Zafatek成为全球上市的首个每周口服一次的降糖药,同时也代表着武田在糖尿病市场投下的一枚重磅炸弹!

2015年3月26日讯 /生物谷BIOON/ --日本制药巨头武田(Takeda)近日宣布,糖尿病新药Zafatek(trelagliptin succinate,曲格列汀琥珀酸盐)获日本卫生劳动福利部(MHLW)批准,用于2型糖尿病的治疗。此次批准,标志着Zafatek成为全球上市的首个每周口服一次的降糖药,同时也代表着武田在糖尿病市场投下的一枚重磅炸弹!

Zafatek由武田和Furiex研发,该药是一种超长效二肽基肽酶IV(DPP-4)抑制剂,每周口服一次,而市场上同类DPP-4抑制剂需要每天口服一次,Zafatek的用药优势无疑将为糖尿病患者提供了更为方便的治疗选择,有望大幅改善患者的便利性和依从性。

目前,美国制药巨头默沙东(Merck)也正在开发一款超长效DPP-4抑制剂omarigliptin,该公司于去年底向日本提交了全球首个监管申请。在临床试验中,omarigliptin疗效媲美自身年销40亿美元的每日一次DPP-4抑制剂Januvia(捷诺维,sitagliptin,西他列汀)。业界认为,omarigliptin将成为默沙东捍卫其口服降糖药市场霸主地位的重要筹码。

据了解,DPP-4抑制剂是首类可通过提高机体自身能力控制血糖水平的新型2型糖尿病药物,可用作单药,也可与其它口服降糖药联用,其作用机制独特,具有不产生低血糖、不引起体重增加,以及副作用小等独特优势,同时引起胃肠道不良反应的发生率亦很低。(生物谷Bioon.com)

英文原文:New Drug Application Approval of Zafatek?Tablets for the treatment of Type 2 Diabetes in Japan

Osaka, Japan, March 26, 2015 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of Zafatek?generic name: trelagliptin succinate), a drug for treating type 2 diabetes.

Zafatek is a once-weekly DPP-4 (dipeptidyl peptidase-IV) inhibitor. It controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones* that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.

The approval granted is based on the safety and efficacy results of multiple clinical phase III studies in patients with type 2 diabetes in Japan. The efficacy of once-weekly trelagliptin succinate was confirmed in all studies, in addition to a good safety and tolerability profile.

Takeda expects that it can provide a new treatment option with Zafatek, the world's first once-weekly DPP-4 inhibitor, and contribute to improvement in drug adherence and continued treatment of patients. The approval granted is a very important milestone for Takeda. Takeda will continue to deliver medicines which patients and healthcare professionals need and contribute to healthcare.
* An insulinotropic gastrointestinal hormone

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