阿斯利康-百时美施贵宝糖尿病新药Xigduo获欧盟批准

关键词:阿斯利康,百时美施贵宝,2型糖尿病,Xigduo,dapagliflozin,SGLT2抑制剂

2014年1月22日讯 /生物谷BIOON/ --阿斯利康(AstraZeneca)和百时美施贵宝(BMS)1月22日宣布,糖尿病新药Xigduo(dapagliflozin+盐酸二甲双胍,5mg/850mg、5mg/1000mg片剂)获欧盟委员会(EC)批准,用于18岁及以上2型糖尿病患者,作为饮食、运动及正接受二甲双胍方案但仍无法充分控制血糖水平的患者的辅助药物,或用于正接受dapagliflozin和二甲双胍联合疗法的患者。

Xigduo由阿斯利康和百时美施贵宝达成的糖尿病联盟开发,阿斯利康称,将在本季度晚些时候全面接管该单元。

Xigduo为每日2次的单一片剂,由固定剂量的dapagliflozin(达帕格列净,商品名:Forxiga)和盐酸二甲双胍组成,这2种成分具有互补性的作用机制,能够帮助改善血糖控制。

Forxiga为日服1次的药物,用于改善血糖控制,该药是首个获批的选择性、可逆性钠-葡萄糖协同转运蛋白(SGLT2)抑制剂类药物,目前已获欧盟、阿根廷、澳大利亚、巴西、墨西哥、冰岛、挪威、新西兰等国批准,用作饮食、运动结合其他降糖药(包括胰岛素)仍无法达到充分血糖控制的2型糖尿病成人患者的辅助药物,也可作为一种单药疗法用于对二甲双胍不耐受的患者。

Forxiga具有与当前糖尿病药物不同的独特作用模式,独立于胰岛素发挥作用,在肾脏中选择性抑制SGLT2,可帮助患者从尿液中排出多余的葡萄糖。SGLT2是一类特异性分布在肾脏近曲小管S1段的葡萄糖转运体,其生理作用是促进葡萄糖在肾小球的重吸收。

此外,在临床研究中,FORXIGA也表现出对体重及血压的降低作用。(生物谷Bioon.com)

英文原文:AstraZeneca's diabetes drug Xigduo approved in Europe

Wednesday, 22 January 2014

AstraZeneca and Bristol-Myers Squibb today announced that Xigduo? (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorisation by the European Commission for the treatment of type 2 diabetes in the European Union (EU). Xigduo combines dapagliflozin (trade name Forxiga?), a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control, in a twice daily tablet. This is the first regulatory approval for a fixed dose combination of an SGLT2 inhibitor and metformin.

Xigduo is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control. It is indicated in patients inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of dapagliflozin and metformin as separate tablets.

Forxiga was the first medicine in the SGLT2 class to gain regulatory approval, having received Marketing Authorisation in the EU for type 2 diabetes in November 2012, and is currently approved for the treatment of type 2 diabetes in 40 countries including the United States (available under the trade name Farxiga?) and Australia.

“Xigduo is an important addition to the range of medicines to help patients manage glycaemic control. We recognise that not all patients are alike and that different treatments are needed, supporting a more personalised approach to disease management,” said Elisabeth Bj?rk, Vice President, Head of Late Phase Cardiovascular and Metabolic Development, AstraZeneca. “Metformin has long been a standard of diabetes care, and with the Xigduo approval, we now have an SGLT2 inhibitor and metformin combination product representing an innovative option for treating adults with type 2 diabetes.”

“Type 2 diabetes is a growing global concern and a range of treatments are needed in order to appropriately manage this disease,” said Fred Fiedorek, Senior Vice President, Head of Development – Cardiovascular & Metabolics, Bristol-Myers Squibb. “The approval of Xigduo offers physicians another valuable treatment choice in the management of this progressive disease.”

(责任编辑:lishuheng)

小编提示:87%用户都在生物谷APP上阅读,扫描立刻下载!

您还可以这样阅读

微信扫一扫,体验新式阅读

打开微信扫描二维码

生物谷微信账号:bioonnews

我们提供多种阅读途径供您选择,随时随地掌握医药生物领域最新资讯。

生物谷微信二维码

    相关资料

    欢迎行业评论、发现、小道消息、官方爆料、采访约稿

    我要投稿   下载App支持编辑