Sipavibart: First Approval

doi:10.1007/s40265-025-02186-w

2025-06-09

PRE

Susan J. Keam *

DOI：10.1007/s40265-025-02186-w

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西帕韦伯特（KAVIGALE®），一种重组人免疫球蛋白（IgG1）抗体，由阿斯利康开发，用于免疫抑制个体的COVID-19暴露前预防。西帕韦伯特于2024年12月在日本获批，用于预防由SARS-CoV-2引起的感染，适用于成人及≥12岁青少年（体重≥40kg），当接种由SARS-CoV-2引起的感染疫苗不被推荐或可能无法达到足够免疫应答时。西帕韦伯特也于2025年1月在欧盟获批，用于因医疗条件或接受免疫抑制治疗而免疫抑制的成人及≥12岁青少年（体重≥40kg）的COVID-19暴露前预防，并于2025年3月在加拿大获批。本文总结了西帕韦伯特开发中的里程碑事件，这些事件促成了其在免疫抑制成人和青少年中首次获批用于COVID-19暴露前预防。

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