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Drugs. 2018 Sep;78(13):1377-1382. doi: 10.1007/s40265-018-0967-6.
Tecovirimat (TPOXX) is an orthopoxvirus-specific antiviral drug developed by SIGA Technologies in conjunction with the US Department of Health and Human Services' Biomedical Advances Research and Development Authority. It acts by inhibiting the activity of the orthopoxvirus VP37 envelope wrapping protein, thereby preventing the formation of egress-competent enveloped virions, which are essential for dissemination of the virus in the host. In July 2018, oral tecovirimat was approved in the USA for the treatment of human smallpox disease caused by variola virus in adults and paediatric patients weighing ≥ 13 kg. Tecovirimat was approved under the US FDA's Animal Rule, in which marketing approval is based on its efficacy in relevant animal models. An intravenous formulation of tecovirimat is undergoing phase I development for the treatment of smallpox infection. This article summarises the milestones in the development of tecovirimat leading to this first approval for the treatment of human smallpox disease in adults and paediatric patients weighing ≥ 13 kg.
特考韦瑞（TPOXX）是一种正痘病毒特异性抗病毒药物，由 SIGA 技术公司与美国卫生与公众服务部的生物医学高级研究与开发局联合开发。它通过抑制正痘病毒 VP37 包膜包裹蛋白的活性，从而阻止具有出芽能力的包膜病毒的形成，这对于病毒在宿主中的传播至关重要。2018 年 7 月，特考韦瑞在 美国获得批准，用于治疗成人和体重≥13kg 的儿科患者由天花病毒引起的人类天花疾病。特考韦瑞是根据美国食品和药物管理局（FDA）的动物规则获得批准的，该规则的营销批准基于其在相关动物模型中的疗效。特考韦瑞的静脉注射制剂正在进行治疗天花感染的 I 期开发。本文总结了特考韦瑞开发过程中的里程碑事件，最终使其获得批准用于治疗体重≥13kg 的成人和儿科患者的人类天花疾病。
