Sotrovimab: First Approval
- PMID: 35286623
- PMCID: PMC8919156
- DOI: 10.1007/s40265-022-01690-7
Sotrovimab: First Approval
Abstract
Sotrovimab (Xevudy®) is a recombinant human monoclonal antibody targeted against the severe acute respiratory syndrome coronavirus 2. It is being developed by Vir Biotechnology in collaboration with GlaxoSmithKline for the treatment of coronavirus disease 2019 (COVID-19). Sotrovimab received its first emergency use authorization in May 2021 for the treatment of COVID-19 in the USA, with interim, emergency or conditional authorizations subsequently granted in several other countries. In December 2021, sotrovimab received its first full approval in the EU for use in adolescents (aged ≥ 12 years and weighing ≥ 40 kg) and adults with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. This article summarizes the milestones in the development of sotrovimab leading to this first approval.
© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Conflict of interest statement
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Young-A Heo is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
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- US Food & Drug Administration. Emergency use authorization: sotrovimab. 2021. https://www.fda.gov. Accessed 25 Jan 2022.
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