The most common side effects include hypersensitivity (allergic) reactions and infusion-related reactions.[10]
Although Sotrovimab was used world-wide against SARS-CoV-2, including in the United States under anFDAemergency use authorization (EUA), the FDA canceled the EUA in April 2022 due to lack of efficacy against theOmicron variant.[16]
In the European Union, sotrovimab is indicated for the treatment ofCOVID-19 in people aged twelve years of age and older and weighing at least 40 kilograms (88 lb) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.[10]
Sotrovimab is given byintravenous infusion, preferably within 5 days of onset of COVID-19 symptoms.[17]
Sotrovimab's development began in December 2019, at Vir Biotechnology when Vir scientists first learned of theinitial COVID-19 outbreak in China.[18] Vir subsidiary Humabs BioMed had already compiled a library of frozen blood samples from patients infected withviral diseases, including two samples from patients infected withSARS-CoV-1.[18] Vir scientists obtained samples of the novelSARS-CoV-2 virus and mixed them with various antibodies recovered from the old SARS-CoV-1 blood samples.[18] The objective was to identify antibodies effective against both SARS-CoV-1 and SARS-CoV-2.[18] This would imply that the antibodies were targeting highlyconserved sequences and in turn would be more likely to remaineffective againstfuture variants of SARS-CoV-2.[18] In April 2020,Lawrence Berkeley National Laboratory conducted aX-ray crystallography study at Vir's request to investigate how such antibodies bind to SARS-CoV-2 at the molecular level.[18] The Berkeley Lab data helped Vir identify candidates for further study, and Vir eventually settled on a single candidate antibody, S309.[18] Vir collaborated with GlaxoSmithKline to make various refinements to S309, resulting in sotrovimab.[18]
Aninterim analysis of this study reported that sotrovimab reduced the risk of hospitalization for more than 24 hours or death by 85% compared with placebo. Overall 1% of people receiving sotrovimab died or required hospitalization for more than 24 hours compared to 7% of people treated with placebo.[13] The study is ongoing and preliminary results have been published in theNew England Journal of Medicine.[21]
The full analysis of the COMET-ICE trial was published in JAMA and it showed that sotrovimab reduced risk of hospitalization for more than 24 hours or death by 79% compared to placebo (1% for sotrovoimab group and 6% for the placebo group). The trial involved 1057 participants and took place before the omicron variant was prevalent.[22]
Sotrovimab is abiologic product which takes six months to manufacture in living cells.[18] It is produced inChinese hamster ovary cells.[23] At product launch in May 2021, sotrovimab'sactive pharmaceutical ingredient was produced byWuXi Biologics in China and sent to a GlaxoSmithKline plant inParma, Italy for further processing into the finished product.[24] In January 2022, the spread of theSARS-CoV-2 Omicron variant began to render other monoclonal antibodies obsolete and caused global demand for sotrovimab to skyrocket.[24] In response, Vir and GlaxoSmithKline announced they were working withSamsung Biologics on manufacturing sotrovimab at an additional site in South Korea.[24]
In May 2021, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) completed its review on the use of sotrovimab for the treatment of COVID-19. It concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged twelve years and above and weighing at least 40 kilograms (88 lb)) who do not require supplemental oxygen and who are at risk of progressing to severe COVID-19.[13] In December 2021, sotrovimab was authorized for use in the EU.[10][26][27]
In May 2021, the U.S.Food and Drug Administration (FDA) issued anemergency use authorization (EUA) for sotrovimab for the treatment of mild-to-moderate COVID-19 in people aged twelve years and above weighing at least 40 kilograms (88 lb) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.[28][29][23][30]
In August 2021, sotrovimab was granted provisional approval for the treatment of COVID-19 in Australia.[3]
In September 2021, sotrovimab was granted special exception authorization in Japan.[31]
In March 2022, the FDA withdrew the emergency use authorization for sotrovimab in multiple states due to the high frequency of the Omicron BA.2 sub-variant and data showing that the authorized dose of sotrovimab is unlikely to be effective against that sub-variant.[34][35] In April 2022, the FDA withdrew the emergency use authorization for sotrovimab.[16][35]
^abcde"Xevudy EPAR".European Medicines Agency (EMA). 15 December 2021.Archived from the original on 18 December 2021. Retrieved17 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^"COVID-19 medicines".European Medicines Agency (EMA). 14 October 2024. Retrieved14 October 2024.
^ab"FDA Roundup: April 5, 2022".U.S. Food and Drug Administration (Press release). 5 April 2022. Archived fromthe original on 8 April 2022. Retrieved8 April 2022. This article incorporates text from this source, which is in thepublic domain.
This article incorporates text from this source, which is in thepublic domain.
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