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              合肥拓銳生物科技有限公司是一家專業的新藥開發,新藥研發公司

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              全球首個每周一次口服降糖藥曲格列汀trelagliptin獲批!
              2015-3-29
              來源:生物谷  作者:admin  發布時間:2015-03-27
              內容摘要:日本制藥巨頭武田(Takeda)近日宣布,糖尿病新藥Zafatek(trelagliptin succinate,曲格列汀琥珀酸鹽)獲日本衛生勞動福利部(MHLW)批準,用于2型糖尿病的治療。此次批準,標志著Zafatek成為全球上市的首個每周口服一次的降糖藥,同時也代表著武田在糖尿病市場投下的一枚重磅炸彈!

              2015年3月26日訊 /生物谷BIOON/ --日本制藥巨頭武田(Takeda)近日宣布,糖尿病新藥Zafatek(trelagliptin succinate,曲格列汀琥珀酸鹽)獲日本衛生勞動福利部(MHLW)批準,用于2型糖尿病的治療。此次批準,標志著Zafatek成為全球上市的首個每周口服一次的降糖藥,同時也代表著武田在糖尿病市場投下的一枚重磅炸彈!

              Zafatek由武田和Furiex研發,該藥是一種超長效二肽基肽酶IV(DPP-4)抑制劑,每周口服一次,而市場上同類DPP-4抑制劑需要每天口服一次,Zafatek的用藥優勢無疑將為糖尿病患者提供了更為方便的治療選擇,有望大幅改善患者的便利性和依從性。

              目前,美國制藥巨頭默沙東(Merck)也正在開發一款超長效DPP-4抑制劑omarigliptin,該公司于去年底向日本提交了全球首個監管申請。在臨床試驗中,omarigliptin療效媲美自身年銷40億美元的每日一次DPP-4抑制劑Januvia(捷諾維,sitagliptin,西他列?。?。業界認為,omarigliptin將成為默沙東捍衛其口服降糖藥市場霸主地位的重要籌碼。

              據了解,DPP-4抑制劑是首類可通過提高機體自身能力控制血糖水平的新型2型糖尿病藥物,可用作單藥,也可與其它口服降糖藥聯用,其作用機制獨特,具有不產生低血糖、不引起體重增加,以及副作用小等獨特優勢,同時引起胃腸道不良反應的發生率亦很低。(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

              ...(全文約2813字)
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