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Remdesivir: First Approval.
Drugs. 2020 Sep; 80(13):1355-1363.D

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 (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.

Authors+Show Affiliations

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

32870481

Citation

Lamb, Yvette N.. "Remdesivir: First Approval." Drugs, vol. 80, no. 13, 2020, pp. 1355-1363.
Lamb YN. Remdesivir: First Approval. Drugs. 2020;80(13):1355-1363.
Lamb, Y. N. (2020). Remdesivir: First Approval. Drugs, 80(13), 1355-1363. https://doi.org/10.1007/s40265-020-01378-w
Lamb YN. Remdesivir: First Approval. Drugs. 2020;80(13):1355-1363. PubMed PMID: 32870481.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Remdesivir: First Approval. A1 - Lamb,Yvette N, PY - 2020/9/2/pubmed PY - 2020/9/17/medline PY - 2020/9/2/entrez SP - 1355 EP - 1363 JF - Drugs JO - Drugs VL - 80 IS - 13 N2 - 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. SN - 1179-1950 UR - https://www.unboundmedicine.com/medline/citation/32870481/Remdesivir:_First_Approval_ L2 - https://dx.doi.org/10.1007/s40265-020-01378-w DB - PRIME DP - Unbound Medicine ER -