Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, Telangana, India.
Expert Rev Anti Infect Ther. 2023 Jul-Dec;21(9):943-955. doi: 10.1080/14787210.2023.2241638. Epub 2023 Aug 1.
The emergence of the Omicron SARS-CoV-2 variant of concern in late November 2021 presaged yet another stage of the COVID-19 pandemic. Paxlovid, a co-packaged dosage form of two antiviral drugs (nirmatrelvir and ritonavir) developed by Pfizer, received its first FDA Emergency Use Authorization (EUA) and conditional marketing by European Medical Agency in patients at high risk of developing severe COVID-19.
We reviewed the timeline of the drug nirmatrelvir from its discovery to authorization by FDA. After 1 year of its authorization, numerous studies and reports on paxlovid's use and post-use consequences are available. This review summarizes the complete journey of paxlovid from its development, preclinical studies, clinical trials, regulatory approvals, ongoing clinical trials, and safety measures, followed by discussions on recent updates on drug-drug interactions, adverse effects, and relapse of COVID-19.
Paxlovid, a new oral antiviral therapy for COVID-19, has shown promising results in clinical trials and has the potential to be effective against the pandemic, particularly for individuals at high risk of severe illness. Comorbidity usage and pharmacovigilance will play a significant stake in the future of paxlovid development. Second-generation M inhibitors play an important role in the upcoming problems associated with COVID-19.
2021 年 11 月下旬,奥密克戎 SARS-CoV-2 变体的出现预示着 COVID-19 大流行进入了另一个阶段。辉瑞公司开发的两种抗病毒药物(奈玛特韦和利托那韦)的复方制剂帕罗维德(Paxlovid)获得了美国 FDA 的首次紧急使用授权(EUA)和欧洲药品管理局的有条件上市许可,适用于有发展为重症 COVID-19 高风险的患者。
我们回顾了药物奈玛特韦从发现到 FDA 授权的时间线。在获得授权后的 1 年内,有大量关于帕罗维德使用和使用后后果的研究和报告。本综述总结了帕罗维德从开发、临床前研究、临床试验、监管批准、正在进行的临床试验和安全措施的完整历程,随后讨论了最近关于药物相互作用、不良反应和 COVID-19 复发的更新。
帕罗维德是一种新的 COVID-19 口服抗病毒疗法,在临床试验中显示出有希望的结果,有可能有效应对大流行,特别是对有重症风险的个体。合并症使用和药物警戒将在帕罗维德开发的未来中发挥重要作用。第二代 M 抑制剂在即将出现的与 COVID-19 相关的问题中发挥着重要作用。