Keam Susan J
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2025 Jun 9. doi: 10.1007/s40265-025-02186-w.
Sipavibart (KAVIGALE), a recombinant human immunoglobulin (Ig)G1-based antibody, is being developed by AstraZeneca for the pre-exposure prophylaxis of COVID-19 in immunocompromised individuals. Sipavibart was approved in December 2024 in Japan to prevent the onset of infection caused by SARS-CoV-2 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg where vaccination against infection caused by SARS-CoV-2 is not recommended or may not achieve a sufficient immune response. Sipavibart was also approved in the EU for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged ≥ 12 years weighing ≥ 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments in January 2025 and in Canada in March 2025. This article summarizes the milestones in the development of sipavibart leading to this first approval for the pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents.
西帕维巴特（KAVIGALE）是一种基于重组人免疫球蛋白（Ig）G1的抗体，由阿斯利康公司研发，用于免疫功能低下个体的新冠病毒暴露前预防。西帕维巴特于2024年12月在日本获批，用于预防严重急性呼吸综合征冠状病毒2（SARS-CoV-2）在年龄≥12岁、体重≥40千克的成人和青少年中引发感染，这些人群不建议接种SARS-CoV-2感染疫苗或接种后可能无法产生足够的免疫反应。2025年1月，西帕维巴特在欧盟获批，用于年龄≥12岁、体重≥40千克、因疾病或接受免疫抑制治疗而免疫功能低下的成人和青少年的新冠病毒暴露前预防；2025年3月在加拿大获批。本文总结了西帕维巴特研发过程中的重要节点，这些节点促成了其首次获批用于免疫功能低下的成人和青少年的新冠病毒暴露前预防。
