Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2022 Jun;82(9):1001-1010. doi: 10.1007/s40265-022-01731-1.
Tixagevimab 150 mg and cilgavimab 150 mg (EVUSHELD 150 mg + 150 mg solution for injection; tixagevimab + cilgavimab) is an intramuscular (IM) long-acting monoclonal antibody combination developed by AstraZeneca for the prevention and treatment of COVID-19. In March 2022, tixagevimab + cilgavimab was approved in the UK for pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and who are unlikely to mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended, and in the EU for the prevention of COVID-19 in adults and adolescents aged ≥ 12 years and weighing ≥40 kg. In December 2021, tixagevimab + cilgavimab was granted Emergency Use Authorization by the US FDA for the pre-exposure prophylaxis of COVID-19 in adults and paediatric individuals (≥ 12 years of age and weighing ≥ 40 kg). This article summarizes the milestones in the development of tixagevimab + cilgavimab leading to this first approval for pre-exposure prophylaxis of COVID-19 in individuals who are not currently infected with SARS-CoV-2.
替沙格韦单抗 150mg 和西加韦单抗 150mg（EVUSHELD 150mg+150mg 注射液；替沙格韦单抗+西加韦单抗）是由阿斯利康公司开发的一种肌内（IM）长效单克隆抗体组合药物，用于预防和治疗 COVID-19。2022 年 3 月，替沙格韦单抗+西加韦单抗在英国获得批准，用于未感染 SARS-CoV-2 的成年人的 COVID-19 暴露前预防，这些人没有最近接触过 SARS-CoV-2 感染者的已知暴露史，并且不太可能对 COVID-19 疫苗产生足够的免疫反应，或者不建议他们接种 COVID-19 疫苗。在欧盟，替沙格韦单抗+西加韦单抗被批准用于预防 12 岁及以上且体重≥40kg 的成年人和青少年的 COVID-19。2021 年 12 月，替沙格韦单抗+西加韦单抗获得美国 FDA 的紧急使用授权，用于未感染 SARS-CoV-2 的成年人和儿科个体（≥12 岁且体重≥40kg）的 COVID-19 暴露前预防。本文总结了替沙格韦单抗+西加韦单抗开发过程中的重要里程碑，最终首次批准用于未感染 SARS-CoV-2 的个体的 COVID-19 暴露前预防。
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