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Xigduo (dapagliflozin and metformin hydrochloride)

ID号：713 发布日期： 2014-08-24 截止日期：不限地区：全国浏览次数：95

名称：达格列净+二甲双胍片
英文名：dapagliflozin / metformin
商品名：Xigduo
规格：5 mg/850 mg 5 mg/1000 mg
厂家：施贵宝-阿斯利康
196片一盒，
Xigduo 5 mg/1000 mg Filmtabletten - OP(60x1); Filmtablette; Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House
Allgemeine Angaben
Eingangsnummer : 2710995
Arzneimittelname: Xigduo 5 mg/1000 mg Filmtabletten - OP(60x1)
Darreichungsform : Filmtablette

Administrative Daten

Antragsteller:    Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House

Verkehrsfähig : ja
Zulassungs-/Reg-Nr.(AMG76) : EU/1/13/900/011

Zusammensetzung

Arzneilich wirksame Bestandteile
ASK-Nr. Stoffname Stoffmenge
   Dapagliflozin--(2S)-Propan-1,2-diol (1:1) 1 H<2>O    6.15mg
   Metforminhydrochlorid    1000.mg

Xigduo 5 mg/850 mg Filmtabletten - OP(60x1); Filmtablette; Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House
Allgemeine Angaben
Eingangsnummer : 2710989
Arzneimittelname: Xigduo 5 mg/850 mg Filmtabletten - OP(60x1)
Darreichungsform : Filmtablette

Administrative Daten

Antragsteller: Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House

Verkehrsfähig : ja
Zulassungs-/Reg-Nr.(AMG76) : EU/1/13/900/005

Zusammensetzung

Arzneilich wirksame Bestandteile
ASK-Nr. Stoffname Stoffmenge
Dapagliflozin--(2S)-Propan-1,2-diol (1:1) 1 H<2>O 6.15mg
Metforminhydrochlorid 850.mg

LONDON & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Xigduo™ (dapagliflozin and metformin hydrochloride) for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control 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.

Xigduo™ combines dapagliflozin (tradename Forxiga®), a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride in a twice daily tablet. This is the first CHMP recommendation for a SGLT2 and metformin hydrochloride fixed dosage combination. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries plus Iceland and Norway.

Xigduo™ combines Forxiga and metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control. Forxiga, the first medicine in the SGLT2 class to gain regulatory approval, is currently approved for the treatment of type 2 diabetes in the European Union, Argentina, Australia, Brazil, Iceland, Mexico, Norway and New Zealand.

About SGLT2 Inhibition

The kidney plays an important role in maintaining normal glucose balance by filtering and reabsorbing glucose from circulation. SGLT2, a sodium-glucose cotransporter found predominantly in the kidney, is responsible for the majority of glucose reabsorption. In patients with type 2 diabetes, the capacity of the kidney to reabsorb glucose is increased by approximately 20%, further exacerbating the hyperglycemia associated with the disease. Selective inhibition of SGLT2 reduces the reabsorption of excess glucose and enables its removal via the urine.

About Diabetes

In 2013, diabetes was estimated to affect more than 380 million people worldwide. The preva lence of diabetes is projected to reach more than 592 million by 2035. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease characterized by insulin resistance and dysfunction of beta cells in the pancreas, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.

阿斯利康和百时美施贵宝公司今天宣布，欧洲药品管理局（EMA）的人用医药产品委员会（CHMP）已对批准Xigduo™（达格列净的和盐酸二甲双胍）治疗为18岁以上的成年人的2型糖尿病采取了积极的意见，CHMP建议将Xigduo™ 用于无法仅用基于二甲双胍治疗方案控制血糖或正接受dapagliflozin的和二甲双胍治疗但是分别给药的患者作为饮食和运动改善血糖控制情况外的增加辅助治疗。

Xigduo™组合钠-葡萄糖协同转运蛋白2（SGLT2）选择性可逆抑制剂达格列净（dapagliflozin，商品名Forxiga®）和盐酸二甲双胍，并制成片剂，该片剂需要每天服务两次。这是CHM认可的第一个SGLT2和盐酸二甲双胍的固定剂量组合。目前，CHMP的积极意见正由由欧洲委员会审核，该委员会有权批准药品在欧盟国家上市。最终的决定将适用于所有28个欧洲联盟会员国以及冰岛和挪威。

Xigduo™结合Forxiga和盐酸二甲双胍两种具有互补性作用机制的抗高血糖产品以改善血糖控制。Forxiga是第一个获得监管部门批准的SGLT2药物，目前已被多个国家与地区被批准用于2型糖尿病，包括欧盟、阿根廷、澳大利亚、巴西、冰岛、墨西哥、挪威和新西兰。

关于 SGLT2 抑制剂：

肾脏通过从循环中过滤和重吸引葡萄糖调节体内葡萄糖水平，在维持血糖平衡中起到重要作用。SGLT2（钠-葡萄糖协同转运蛋白）主要在肾脏上表达，负责大部的葡萄糖的重吸收。在2型糖尿病患者中，肾脏的重吸收葡萄糖的能力提高约20％，进一步加剧了与疾病相关的高血糖症。SGLT2的选择性抑制可减少过量的葡萄糖的重吸收，并通过尿清除。