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Drugs. 2020 Sep;80(13):1355-1363. doi: 10.1007/s40265-020-01378-w.
The antiviral agent remdesivir (Veklury; Gilead Sciences), nucleotide analogue prodrug, has broad-spectrum activity against viruses from several families. Having demonstrated potent antiviral activity against coronaviruses in preclinical studies, remdesivir emerged as a candidate drug for the treatment of the novel coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, during the current global pandemic. Phase III evaluation of remdesivir in the treatment of COVID-19 commenced in early 2020 and has thus far yielded promising results. In late May 2020, Taiwan conditionally approved the use of remdesivir in patients with severe COVID-19. This was followed by a rapid succession of conditional approvals in various countries/regions including the EU and Canada. Preceding these conditional approvals, an emergency use authorization for remdesivir had been granted in the USA (on 1 May 2020) and a special approval for emergency use was granted in Japan (on 7 May 2020). This article summarizes the milestones in the development of remdesivir leading to its first conditional approval for the treatment of COVID-19.
抗病毒药物瑞德西韦（Veklury；吉利德科学公司）是一种核苷酸类似物前药，对来自多个科的病毒具有广谱活性。在临床前研究中，瑞德西韦对冠状病毒表现出强大的抗病毒活性，因此在当前全球大流行期间，它成为治疗由严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染引起的新型冠状病毒病 2019（COVID-19）的候选药物。2020 年初开始对瑞德西韦治疗 COVID-19 进行 III 期评估，迄今为止取得了有希望的结果。2020 年 5 月下旬，台湾有条件批准瑞德西韦用于治疗重症 COVID-19 患者。随后，欧盟和加拿大等多个国家/地区也相继有条件批准。在这些有条件批准之前，美国已于 2020 年 5 月 1 日授予瑞德西韦紧急使用授权，日本也于 2020 年 5 月 7 日批准紧急使用。本文总结了瑞德西韦开发过程中的里程碑事件，最终该药首次有条件批准用于治疗 COVID-19。
