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。不过，去年12月，阿斯利康耗资41亿美元，收购了百时美在该联盟中的全部股份，全面接管了该单元。
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无法充分控制血糖水平的2型糖尿病成人患者，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。
Anglo-Swedish drug major AstraZeneca (LSE: AZN)’s type 2 diabetes drug Xigduo (dapagliflozin and metformin hydrochloride) is now available in the UK.
Xigduo is a twice daily tablet that combines Forxiga (dapagliflozin), a selective and reversible inhibitor of SGLT2, with metformin hydrochloride (HCI) and is the first fixed-dose combination of its kind to be available in the UK. It was developed with AstraZeneca’s former partner Bristol-Myers Squibb (NYSE: BMY) but the firm acquired the whole of B-MS’ diabetes alliance in a $4.1 billion deal in December.
Xigduo is now available for use on NHS England and NHS Wales, because the UK’s National Institute for Health and Care Excellence (NICE) and All Wales Medicines Strategy Group (AWMSG) have decided not to appraise it on the basis that existing guidance for dapagliflozin already covers all patients for whom Xigduo would be clinically appropriate. AstraZeneca will submit Xigduo for an abbreviated appraisal by the Scottish Medicines Consortium (SMC).
Improves glycemic control
Xigduo received marketing authorization from the European Commission in January. It is indicated for use in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control. It is indicated for use 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.
Lisa Anson, president, AstraZeneca UK and Ireland, said: “AstraZeneca is proud to have launched the first in class SGLT2 inhibitor - dapagliflozin - for the treatment of type 2 diabetes, and today we launch the first fixed-dose combination of SGLT2 and metformin. There are almost three million people in the UK living with type 2 diabetes and this latest development reinforces AstraZeneca’s long-term commitment to being at the forefront of providing them and the healthcare professionals that treat them, with medicines to manage this increasingly prevalent disease.”
Forxiga (dapagliflozin) was the first medicine in the SGLT2 class to gain regulatory approval, having received European marketing authorization for the treatment of type 2 diabetes in November 2012, and is currently approved for the treatment of type 2 diabetes in 40 countries.
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