赛诺菲公布其长效胰岛素Toujeo治疗青少年糖尿病的3期阳性结果

2019-11-04 不详 MedSci原创

法国制药商赛诺菲(Sanofi)公开了其长效胰岛素Toujeo(甘精胰岛素300单位/ mL)的积极结果,并将其与Lantus(甘精胰岛素100单位/ mL)进行比较,后者在去年失去了专利。EDITION JUNIOR研究评估了Toujeo在6-17岁的1型糖尿病(T1D)儿童和青少年的药效。

法国制药商赛诺菲(Sanofi)公开了其长效胰岛素Toujeo(甘精胰岛素300单位/ mL)的积极结果,并将其与Lantus(甘精胰岛素100单位/ mL)进行比较,后者在去年失去了专利。EDITION JUNIOR研究评估了Toujeo在6-17岁的1型糖尿病(T1D)儿童和青少年的药效。

该实验达到了其主要终点,两种疗法在六个月内的平均血糖均降低了,并且出现了类似的低血糖低血糖)事件的风险,经历严重低血糖和经历高血糖(高血糖)事件的参与者百分比相似。使用Toujeo时,发生严重低血糖和高血糖并伴有酮症的患者在数量上较低。

根据赛诺菲(Sanofi)的说法,该研究的结果已促使欧洲药品管理局人类用药品委员会采纳了积极的意见,建议扩大Toujeo的当前适应症范围,使其用于青少年和儿童中治疗T1D(患病六年及以上)。

赛诺菲全球发展主管Dietmar Berger说:"在全球范围内,患有T1D的年轻人中有50%至80%需要更多的治疗选择,以帮助他们使平均血糖水平低于7.5%。"

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    2020-02-19 baoya
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    2019-11-05 misszhang

    谢谢MedSci提供最新的资讯

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