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.
阿斯利康和施贵宝治疗Ⅱ型糖尿病药物Xigduo获肯定
欧洲药品管理局(EMA)的人用药品委员会(CHMP)已经正面肯定阿斯利康和施贵宝公司的Xigduo(达格列净和盐酸二甲双胍)可用于患有Ⅱ型糖尿病的18岁以上成年人，针对使用二甲双胍或联合使用单片二甲双胍和达格列净仍不能有效控制血糖的病人，Xigduo可作为饮食和运动控制血糖的佐剂。
Xigduo是达格列净和盐酸二甲双胍的结合，每日服用两次。达格列净，商品名Forxiga，是葡萄糖转运蛋白2(SGLT2)的一个选择性、可逆性抑制剂。Xigduo是首个CHMP推荐的SGLT2和剂量不变的盐酸二甲双胍结合的药物。CHMP的正面肯定将由具有批准药物权利的欧洲委员会审核。最终结果将由全部28个欧盟成员国家和冰岛、挪威一同决定。
Xigduo是两种机制互补的抗高血糖药物Forxiga和盐酸二甲双胍的结合，因此它能更有效的控制血糖。Forxiga是首个注册批准的SGLT2类药物，目前批准被用于Ⅱ型糖尿病的治疗。
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。