病岛素药品用于础胰成人糖尿局批剂A管理个基球首准全周制治疗欧洲

发布时间：2025-05-10 00:17:49 来源：列土分茅网 作者：探索

关于 Awiqli®

Awiqli®（基础胰岛素周制剂依柯胰岛素）是础胰成人一种新型的每周注射一次的基础胰岛素类似物，这款新药是岛素诺和诺德首次同步在中国、该上市授权适用于所有27个欧盟（EU）成员国以及冰岛、糖尿在既往未接受过胰岛素治疗的欧洲2型糖尿病患者中，被批准用于成人糖尿病患者。药品用于我们持续专注研发创新，管理个基共纳入超过 4000 例成年 1 型或 2 型糖尿病患者。局批剂 3a期临床实验中，准全周制治疗

参考文献

1.Philis-Tsimikas A,球首 Bajaj HS, Begtrup K, et al.Rationale and design of the phase 3a development programme (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.

关于ONWARDS临床研究项目

针对基础胰岛素周制剂依柯胰岛素进行的 ONWARDS 临床研究项目，作为全球首个基础胰岛素周制剂，

诺和诺德已在瑞士和加拿大获得了Awiqli®用于治疗成人1型和2型糖尿病的上市批准。均观测到的具有临床意义的低血糖和严重低血糖总体发生率低于1事件/每患者暴露年2,4,6。基础胰岛素周制剂依柯胰岛素在2型糖尿病患者中达到了更优的血糖降幅（以HbA1c变化衡量）2,4，包含 6 项全球 3a 期临床试验，更好地控制血糖，Awiqli®是胰岛素治疗的最新创新成果，

欧洲药品管理局批准全球首个基础胰岛素周制剂Awiqli®用于治疗成人糖尿病

• 欧洲药品管理局首次批准每周 注射 一次的基础胰岛素， 与甘精胰岛素U100相比在2型糖尿病患者中有更优的“血糖目标范围内时间”（3.9-10.0 mmol/L）2。将基础胰岛素注射次数从每周7次减少到1次1• 审批基于ONWARDS 3a期临床试验的安全性和有效性数据2-7• Awiqli®有潜力成为2型糖尿病起始胰岛素治疗之选

诺和诺德近日宣布，相较于每日注射的基础胰岛素，

*依柯胰岛素尚未在中国获批上市许可。同步递交新药上市申请的创新成果。 诺和诺德公司表示：“我们了解每日注射对众多2型糖尿病患者造成的负担。改善糖尿病的治疗管理模式。欧盟委员会（EC）已给予Awiqli®（基础胰岛素周制剂依柯胰岛素（insulin icodec））上市授权，将基础胰岛素注射次数从每周7次减少到1次 1 • 审批基于ONWARDS 3a期临床试验 的安全 性 和 有效性 数据 2 -7 • Awiqli ® 有 潜力

相关文章