Sotrovimab: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest 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.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

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Abstract

Sotrovimab (Xevudy®) is a recombinant 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.

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