Xigduo(dapagliflozin and metformin hydrochloride) 达格列净+二甲双胍片
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

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.
糖尿病新药Xigduo（达格列净+二甲双胍）在英国上市
阿斯利康（AstraZeneca）3月11日宣布，在英国推出糖尿病新药Xigduo（dapagliflozin+盐酸二甲双胍，5mg/850mg、5mg/1000mg片剂），该药由阿斯利康和前合作伙伴百时美施贵宝（BMS）达成的全球糖尿病联盟开发。
Xigduo于2014年1月获欧盟批准，作为一种辅助药物，结合饮食、运动用于正接受二甲双胍治疗但仍血糖控制不佳的成人2型糖尿病患者，或用于正接受dapagliflozin和二甲双胍联合疗法的成人患者。
Xigduo为每日2次的单一片剂，由固定剂量的dapagliflozin（达格列净 ，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。
dapagliflozin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。
dapagliflozin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，dapagliflozin也表现出对体重及血压的降低作用。