CHMP建议批准阿斯利康和百时美施贵宝降糖新药Xigduo

阿斯利康（AstraZeneca）和百时美施贵宝（BMS）11月22日宣布，降糖药Xigduo（dapagliflozin+盐酸二甲双胍）获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准Xigduo，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是一种每日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，该药是获得监管部门批准的首个选择性、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。

英文原文：Xigduo? (dapagliflozin and metformin hydrochloride) Receives Positive CHMP Opinion in the European Union for the Treatment of Type 2 Diabetes

Friday, November 22, 2013 8:45 am EST

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 prevalence 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.

AstraZeneca/Bristol-Myers Squibb Diabetes Alliance

Dedicated to addressing the global burden of diabetes by advancing individualized patient care, AstraZeneca and Bristol-Myers Squibb are working in collaboration to research, develop and commercialize a versatile portfolio of innovative treatment options for diabetes and related metabolic disorders that aim to provide treatment effects beyond glucose control.