• 歐洲藥品管理局首次批準每周 注射 一次的欧洲基礎胰島素，將基礎胰島素注射次數從每周7次減少到1次 1 • 審批基於ONWARDS 3a期臨床試驗 的药品用于安全 性 和 有效性 數據 2 -7 • Awiqli ® 有 潛力
諾和諾德近日宣布，歐盟委員會（EC）已給予Awiqli®（基礎胰島素周製劑依柯胰島素（insulin icodec））上市授權，局批剂用於治療成人糖尿病患者。准全周制治疗該上市授權適用於所有27個歐盟（EU）成員國以及冰島、球首挪威和列支敦士登。础胰成人
諾和諾德已在瑞士和加拿大獲得了Awiqli®用於治療成人1型和2型糖尿病的上市批準。這款新藥是諾和諾德首次同步在中國、歐盟與美國完成臨床試驗，同步遞交新藥上市申請的創新成果。
*依柯胰島素尚未在中國獲批上市許可。
關於 Awiqli®
Awiqli®（基礎胰島素周製劑依柯胰島素）是一種新型的每周注射一次的基礎胰島素類似物，被設計為一周一次皮下注射即可滿足一整周的基礎胰島素需求，被批準用於成人糖尿病患者。
關於ONWARDS臨床研究項目
針對基礎胰島素周製劑依柯胰島素進行的 ONWARDS 臨床研究項目，包含 6 項全球 3a 期臨床試驗，其中一項包含真實世界研究元素，共納入超過 4000 例成年 1 型或 2 型糖尿病患者。所有試驗均達成其主要終點2-7。
參考文獻
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