Remdesivir: First Approval
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ADISINSIGHT REPORT
Remdesivir: First Approval Yvette N. Lamb1
© Springer Nature Switzerland AG 2020
Abstract 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 (COVID19), 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.
Remdesivir (Veklury®): Key points
1 Introduction
A nucleotide analogue prodrug is being developed by Gilead Sciences for the treatment of COVID-19
Remdesivir ( Veklury ®; Gilead Sciences), a prodrug of an adenosine nucleotide analogue, is an antiviral agent with broad-spectrum activity against viruses from several families [1–4]. Remdesivir was previously under development for the treatment of Ebola virus disease in the wake of the 2014-2016 Ebola outbreak in West Africa. While it was a promising therapeutic agent for Ebola virus disease in preclinical studies [4], monoclonal antibodies outperformed remdesivir in a phase III clinical trial [5] and remdesivir is no longer being developed in this indication. The antiviral activity of remdesivir against coronaviruses, however, has rendered the drug of great interest during the current global pandemic. The novel coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, was first reported in Wuhan, China, in December 2019 [6]. The World Health Organization declared COVID-19 a Public Health Emergency of International Concern on 30 January 2020 and a pandemic on 11 March 2020 [6], spurring an international effort to rapidly identify treatments that might ease the burden on healthcare systems. Phase III trials of remdesivir in COVID-19 were initiated as early as February 2020. Based on data from the multinational phase III ACTT-1 and SIMPLE-severe trials,
Received its first emergency use authorization on 1 May 2020 in the USA Received its first conditional approval in late May 2020 in Taiwan Approved for use in patients with severe COVID-19
Enhanced material for or this AdisInsight Report can be found at https://doi.org/10.6084/m9.
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