诺和诺德近日宣布，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，用于治疗成人糖尿病患者。该上市授权适用于所有27个欧盟（EU）成员国以及冰岛、挪威和列支敦士登。
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。这款新药是诺和诺德首次同步在中国、欧盟与美国完成临床试验，同步递交新药上市申请的创新成果。
*依柯胰岛素尚未在中国获批上市许可。
关于 Awiqli®
Awiqli®（基础胰岛素周制剂依柯胰岛素）是一种新型的每周注射一次的基础胰岛素类似物，被设计为一周一次皮下注射即可满足一整周的基础胰岛素需求，被批准用于成人糖尿病患者。
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，包含 6 项全球 3a 期临床试验，其中一项包含真实世界研究元素，共纳入超过 4000 例成年 1 型或 2 型糖尿病患者。所有试验均达成其主要终点2-7。
参考文献
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