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. Supplementary Information The online version contains supplementary material available at 10.1007/s40265-022-01690-7.

Lack of efficacy for sotrovimab use in patients with COVID-19: A meta-analysis

“…Sotrovimab is a neutralizing monoclonal antibody targeting the conserved epitope on the spike protein receptor of SARS-CoV-2. It was granted emergency use authorization by the United States Food and Drug Administration in May 2021 with several countries closely following suit 2 . Given as a single 500 mg IV infusion, sotrovimab inhibits the fusion of viral and cell membranes to decrease viral internalization 2 .…”

“…It was granted emergency use authorization by the United States Food and Drug Administration in May 2021 with several countries closely following suit 2 . Given as a single 500 mg IV infusion, sotrovimab inhibits the fusion of viral and cell membranes to decrease viral internalization 2 . In addition, it was reported that the Omicron spike was resistant against most therapeutic antibodies but remained susceptible to inhibition by sotrovimab 2 , 3 .…”

“…Given as a single 500 mg IV infusion, sotrovimab inhibits the fusion of viral and cell membranes to decrease viral internalization 2 . In addition, it was reported that the Omicron spike was resistant against most therapeutic antibodies but remained susceptible to inhibition by sotrovimab 2 , 3 . However, on March 25, 2022, the FDA revised the authorization for sotrovimab to limit its use for the treatment of COVID-19 in certain U.S. regions with high frequency of the omicron BA.2 subvariant.…”

Antibodies against SARS-CoV-2 after natural infection in healthcare workers and clinical characteristics as putative antibody production prediction

“…Recent research indicates a benefit of convalescent plasma therapy and the use of synthetic monoclonal antibodies in SARS-CoV-2 patients [8] , [9] . Neutralizing antibodies are the presumed active component of these treatments.…”

Decoding the Effects of Spike Receptor Binding Domain Mutations on Antibody Escape Abilities of Omicron Variants

“…21.500931 doi: bioRxiv preprint Sotrovimab also received emergency approval for mild to moderate COVID19. 19 It is effective against both SARS-CoV and SARS-CoV2, as it recognizes the common epitopes in both the RBDs. The combination of anti-RBD mAbs, tixagevimab (AZD8895)/cilgavimab (AZD1061), also received emergency approval from FDA.…”