欧洲药品操持局允许齐球尾个底子胰岛素周制剂Awiqli®用于治疗成人糖尿病

发布时间：2025-12-21 09:44:12 来源：健康之道网 作者：药膳食谱推荐

欧洲药品操持局允许齐球尾个底子胰岛素周制剂Awiqli®用于治疗成人糖尿病

• 欧洲药品操持局初次允许每一周 注射 一次的欧洲底子胰岛素，将底子胰岛素注射次数从每一周7次削减到1次 1 • 审批基于ONWARDS 3a期临床真验 的药品胰岛®用于治牢靠 性 战 实用性 数据 2 -7 • Awiqli ® 有 后劲

诺战诺德远日宣告掀晓，欧盟委员会（EC）已经给以Awiqli®（底子胰岛素周制剂依柯胰岛素（insulin icodec））上市授权，局允用于治疗成人糖尿病患者。许齐该上市授权开用于残缺27个欧盟（EU）成员国战冰岛、球尾挪威战列支敦士登。个底

诺战诺德已经正在瑞士战减拿小大患上到了Awiqli®用于治疗成人1型战2型糖尿病的上市允许。那款新药是诺战诺德初次同步正在中国、欧盟与好国实现临床真验，同步递交新药上市恳求的坐异功能。

*依柯胰岛素借出有正在中国获批上市许诺。

闭于 Awiqli®

Awiqli®（底子胰岛素周制剂依柯胰岛素）是一种新型的每一周注射一次的底子胰岛素远似物，被设念为一周一次皮下注射即可知足一整周的底子胰岛素需供，被允许用于成人糖尿病患者。

闭于ONWARDS临床钻研名目

针对于底子胰岛素周制剂依柯胰岛素妨碍的 ONWARDS 临床钻研名目，收罗 6 项齐球 3a 期临床真验，其中一项收罗真在天下钻研元素，共纳进逾越 4000 例成年 1 型或者 2 型糖尿病患者。残缺真验均告竣其尾要起面2-7。

参考文献

1.Philis-Tsimikas A, Bajaj HS, Begtrup K, et al.Rationale and design of the phase 3a development progra妹妹e (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023;25:331-341.

2.Rosenstock J, Bain SC, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. 2023;389:297-308.

3.Philis-Tsimikas A, Asong M, Franek E, et al.Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023;11:414-425.

4.Lingvay I, Asong M, Desouza C, et al. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023;330:228-237.

5.Mathieu C, Asbjornsdottir B, Bajaj HS, et al.Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023;401:1929-1940.

6.Bajaj HS, Aberle J, Davies M, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : A Randomized Trial. Ann Intern Med. 2023;176:1476-1485.

7.Russell-Jones D, Babazono T, Cailleteau R, et al.Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial. Lancet. 2023;402:1636-1647.

8.Novo Nordisk. Importance of initiation and titration. Company investor presentation, 2020.

9.Rubino A, McQuay LJ, Gough SC, et al. Delayed initiation of subcutaneous insulin therapy after failure of oral glucose-lowering agents in patients with Type 2 diabetes: a population-based analysis in the UK. Diabet Med. 2007;24:1412-8.

10.Hosomura N, Malmasi S, Timerman D, et al.Decline of insulin therapy and delays in insulin initiation in people with uncontrolled diabetes mellitus. Diabet Med. 2017;34:1599-1602.

11.Peyrot M, Barnett AH, Meneghini LF, et al.Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012;29:682-9.

12.LAI 287 Prescription and Preference Driver 2019. Base: All patients (n = 391). Markets: USA, UK, France, Germany, China and Japan.

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