The study is ongoing and preliminary results have been published in the New England Journal of Medicine.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. Manufacturing
Sotrovimab is a biologic product which takes six months to manufacture in living cells. It is produced in Chinese hamster ovary cells. At product launch in May 2021, sotrovimabs active pharmaceutical ingredient was produced by WuXi Biologics in China and sent to a GlaxoSmithKline plant in Parma, Italy for further processing into the finished product. In January 2022, the spread of the SARS-CoV-2 Omicron variant began to render other monoclonal antibodies obsolete and caused global demand for sotrovimab to skyrocket. In response, Vir and GlaxoSmithKline announced they were working with Samsung Biologics on manufacturing sotrovimab at an additional site in South Korea. Society and culture
Economics
In 2021, the United States government agreed to purchase 1.5 million doses of the drug at $2,100 per dose. Legal status
In May 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) completed its review on the use of sotrovimab for the treatment of COVID-19.
Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. It is under development by GlaxoSmithKline and Vir Biotechnology, Inc. Sotrovimab is designed to attach to the spike protein of SARS-CoV-2.The most common side effects include hypersensitivity (allergic) reactions and infusion-related reactions. Medical uses
In the European Union, sotrovimab is indicated for the treatment of COVID-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.Sotrovimab is given by intravenous infusion, preferably within 5 days of onset of COVID-19 symptoms. Development and mechanism of action
Sotrovimabs development began in December 2019, at Vir Biotechnology when Vir scientists first learned of the initial COVID-19 outbreak in China. Vir subsidiary Humabs BioMed had already compiled a library of frozen blood samples from patients infected with viral diseases, including two samples from patients infected with SARS-CoV-1. Vir scientists obtained samples of the novel SARS-CoV-2 virus and mixed them with various antibodies recovered from the old SARS-CoV-1 blood samples. The objective was to identify antibodies effective against both SARS-CoV-1 and SARS-CoV-2. This would imply that the antibodies were targeting highly conserved sequences and in turn would be more likely to remain effective against future variants of SARS-CoV-2.