GSK/Vir neutralizing antibody sotrovimab was granted emergency use authorization by the U.S. FDA

On May 26, the US FDA granted emergency use authorization (EUA) for the COVID-19 monoclonal antibody drug sotrovimab for mild to moderate patients who tested positive for the virus and have a high risk of developing severe COVID-19 (including hospitalization and death) Adults and adolescents (12 years and older, weighing at least 40 kg) patients.

Sotrovimab is a neutralizing antibody developed by GlaxoSmithKline and Vir Biotechnology.
This approval will provide another effective treatment plan for the fight against the COVID-19 pandemic.
At present, this epidemic is still raging in many countries around the world, and new variants are constantly appearing, and the emergence of these variants may make some drugs less effective, such as certain neutralizing antibodies.

Data from the Phase 3 COMET-ICE trial showed that among high-risk, newly diagnosed COVID-19 patients, sotrovimab can reduce hospitalization or mortality by 85% compared with placebo.
The number of patients enrolled in this trial is equal to or exceeds the number of patients in key clinical trials of Regeneron dual antibody cocktail therapy (casirivimab+imdevimab) and Eli Lilly dual antibody cocktail therapy (etesevimab+bamlanivimab) in key clinical trials.
However, Eli Lilly’s dual antibody cocktails have been eliminated in Illinois and Massachusetts because the therapy proved ineffective against a new variant.

On the contrary, sotrovimab, as a single antibody, seems to be able to neutralize every variant that is constantly emerging.
Sotrovimab was originally isolated from SARS survivors and was selected by Vir for development at the beginning of the pandemic because it can broadly neutralize most viruses in the coronavirus family.
Bob Nelsen, Vir founder and venture capitalist, believes that throughout the pandemic, unlike competing products, sotrovimab is likely to continue to work even if the virus mutates.

Vir’s George Scangos said: “sotrovimab has been shown to retain activity against all known variants in in vitro tests, including new variants from India.
I believe that sotrovimab is used to prevent the current COVID-19 pandemic and future coronaviruses.
A key new treatment plan for the outbreak.
"

Nevertheless, the exact impact of Vir antibodies on the COVID-19 pandemic remains unclear.
Even before vaccines were widely used, antibody therapies were not widely used in the United States, although they were effective in preventing hospitalization and death.

George Scangos also talked about the possibility of deploying sotrovimab around the world, but although Vir promised at the end of 2020 that it will provide millions of doses in 2021, a GSK spokesperson declined to say how many doses are currently ready.
They pointed out that sotrovimab will take some time to launch.

GSK and Vir stated that they will provide sotrovimab to appropriate patients diagnosed with COVID-19 in the United States in the next few weeks.
At present, the two parties are also actively cooperating with government agencies around the world to provide sotrovimab to patients in need of treatment.

The COVID-19 neutralizing antibody therapies previously granted EUA have received orders from the U.
S.
government, which are purchased and distributed by the government.
According to a report by the foreign biomedical media EndPoints News, sotrovimab does not seem to have received a government order, and Vir and GSK will open the market themselves.
Spokespersons of the two parties stated that sotrovimab will be priced at a price similar to that charged by Eli Lilly and Regeneron for each dose of the drug.
(Sina Pharmaceutical News)

Reference source: FDA authorizes Vir-GSK antibody as variants threaten Eli Lilly mAb