重磅！首款口服司美格魯肽在國內獲批上市

剛剛，國傢藥監局發佈藥品批準證明文件送達信息，諾和諾德司美格魯肽片獲批上市，用於治療 2 型糖尿病。這也是國內首個獲批上市的口服 GLP-1 受體激動劑。

圖源：國傢藥監局政務服務門戶網站

此前，口服司美格魯肽 3mg、7mg 和 14mg 已獲得 FDA 批準用於 2 型糖尿病。

司美格魯肽屬 GLP-1 受體激動劑（GLP-1RA）類降糖藥。GLP-1 是一種腸促胰素，以葡萄糖濃度依賴的方式促進胰島素分泌，抑制胰高糖素分泌從而降低血糖，同時還有延緩胃排空的作用。

而正因為「延緩胃排空」這個附帶作用，司美格魯肽除了能完成降糖本職之外，兼有抑制食欲的作用，使減肥成為其第二適應證，也因此大爆為新晉的現象級藥物。

2023 年 3 月 24 日，諾和諾德公佈了口服版司美格魯肽 III 期臨床數據，結果顯示，每日一次口服 14mg、25mg 和 50mg 司美格魯肽的患者，52 周（1 年）後體重分別減輕了 4.4kg、6.7kg 和 8.0kg。

諾和諾德表示，這項為期 68 周的 IIIb 期療效與安全性試驗，重點在對比更大劑量（25mg、50mg）司美格魯肽與此前已獲批的 14mg 劑量在治療 2 型糖尿病中的效果。

目前，該臨床試驗達到了主要終點，在治療第 52 周時，25mg 和 50mg 的口服司美格魯肽對糖化血紅蛋白（HbA1c）的降低效果和減重效果均要顯著優於 14mg 劑量，並展現出良好的安全性和耐受性。

來源：丁香園

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