2023年1月26日格林尼治时间18:15
美国食品和药物管理局(FDA)表示，澳门葡京网赌游戏的 Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld 不保留体外中和对抗.
The FDA has notified 澳门葡京网赌游戏 that the Agency will make a determination about reinstating authorisation of Evusheld if the national prevalence of resistant variants decreases to 90% or less on a sustained basis. 美国政府全面推荐 Evusheld product be retained and properly stored in the event that variants susceptible to Evusheld, including those currently circulating at lower prevalence, become more prevalent in the future.
根据体外假病毒检测实验室数据， Evusheld 不能中和欧米克隆亚变体BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2、XBB和XBB.1.5.1 The combined proportion of COVID-19 cases caused by these subvariants is currently greater than 90% in the US, according to the Centers for Disease Control and Prevention (CDC) Nowcast modelling data.2
澳门葡京网赌游戏 will continue to work with the FDA and other health authorities to collect, 评估和分享有关的数据 Evusheld 和SARS-CoV-2变种. Evusheld currently remains authorised in other countries w在这里 it is approved for COVID-19 pre-exposure prophylaxis and treatment, 包括欧盟和日本.
新一代长效抗体I/III期试验正在进行中
澳门葡京网赌游戏 has initiated the SUPERNOVA Phase I/III trial to investigate the safety and efficacy of a next-generation long-acting antibody (LAAB) in COVID-19 pre-exposure prophylaxis in an immunocompromised population. 在体外实验室研究, the new LAAB has been shown to neutralise all SARS-CoV-2 variants tested to date, including variants that have proved resistant to other monoclonal antibodies.3 澳门葡京网赌游戏 is aiming to make the new LAAB available in the second half of 2023, 根据试验读数和监管审查.
About 2% of the global population is considered at increased risk of an inadequate response to COVID-19 vaccination and could benefit from monoclonal antibodies for COVID-19 protection.4,5
笔记
Evusheld
Evusheld is a combination of two long-acting antibodies - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to 澳门葡京网赌游戏 in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein6 and were optimised by 澳门葡京网赌游戏 with half-life extension and reduction of Fc effector function and complement C1q binding.7 The half-life extension more than triples the durability of its action compared to conventional antibodies;8-10 来自PROVENT III期试验的数据显示保护持续6个月.11 The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, 而不是抑制, 感染和/或疾病.12
Evusheld 是在美国政府的支持下开发的吗, including federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, 生物, 放射性和核防御, 合同编号为W911QY-21-9-0001.
根据和范德比尔特的许可协议条款, 澳门葡京网赌游戏将为未来的净销售额支付个位数的版税.
澳门葡京网赌游戏
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, 发展, 以及肿瘤学处方药的商业化, 罕见疾病, 和澳门葡京赌博游戏, 包括心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门葡京网赌游戏 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问澳门葡京网赌游戏.并在推特上关注公司@澳门葡京网赌游戏.
参考文献
1. US Food and Drug Administration Fact Sheet for Healthcare Providers: Emergency Use Authorization for EvusheldTM (Tixagevimab与Cilgavimab复合包装). http://www.食品及药物管理局.gov/media/154701/download[最后访问:2023年1月]
2. Centers for Disease Control and Prevention CDC COVID Data Tracker: Variant Proportions. http://covid.疾病预防控制中心.gov/covid-data-tracker/#variant-proportions [Last accessed: January 2023]
3. 澳门葡京网赌游戏数据文件号:REF-173560
4. Harpaz R，等. 2013年美国成人免疫抑制患病率. 《澳门葡京网赌游戏》. 2016;316(23):2547-2548. doi: 10.1001 /贾马.2016.16477
5. 澳门葡京网赌游戏数据文件编号:REF-129335
6. 董杰，等. Genetic and Structural Basis for SARS-CoV-2 Variant Neutralization by a Two-Antibody Cocktail. Nat Microbiol. 2021;6(10):1233-1244
7. Loo YM，等. AZD7442 Demonstrates Prophylactic and Therapeutic Efficacy in Non-Human Primates and Extended Half-Life in Humans. 科学与医学 . 2022; 14 (635): eabl8124
8. Robbie GJ，等. 一种新型的fc修饰人源化单克隆抗体, Motavizumab-YTE, 健康成人的半衰期是否延长. 抗菌剂化学试剂. 2013;57(12):6147-6153
9. Griffin MP，等. 安全, 耐受性, MEDI8897的药代动力学研究, the 呼吸 Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, 健康成人. 抗菌剂化学试剂. 2017;61(3)
10. 多玛考斯基，杰比等人. 安全, MEDI8897的耐受性和药代动力学, an Extended Half-Life Single-Dose 呼吸 Syncytial Virus Prefusion F-Targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. 儿科传染病J. 2018;37(9):886-892
11. Levin MJ，等. Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19. [英]医学. 2022;386(23):2188-2200
12. van Erp EA，等. Fc-媒体ted Antibody Effector Functions During 呼吸 Syncytial Virus Infection and Disease. 前面Immunol. 2019; 10(3月)
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