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mAbs Seeks Intramuscular Administration Authorization for Early COVID-19 Treatment

January 13, 2022 • 9:04 am CST
(Precision Vaccinations)

San Francisco-based Vir Biotechnology, Inc. and GSK today announced they submitted an application to the U.S. FDA requesting an amendment to the Emergency Use Authorization (EUA) for SARS-CoV-2 virus monoclonal antibody (mAbs) sotrovimab to include intramuscular administration.

The FDA granted the initial EUA for sotrovimab in May 2021 as an investigational single-dose intravenous (500 mg) infusion SARS-CoV-2 mAbs.

Under the current EUA, sotrovimab can be used to treat mild-to-moderate COVID-19 in adults and certain pediatric patients 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.

Sotrovimab is not FDA-Approved for this use, as limited clinical data is available.

Additionally, GSK and Vir are partnering to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection.

Sotrovimab is contraindicated in patients who have a history of anaphylaxis to sotrovimab or any excipients in the formulation. This is because serious and unexpected adverse events that have not been previously reported with sotrovimab use may occur.

The University of Oxford is also studying Sotrovimab among patients hospitalized with COVID-19 in the United Kingdom as part of the Randomized Evaluation of COVID-19 Therapy (RECOVERY) Clinical Trial.

Since October 2021, about 385,060 doses have been shipped in the U.S.

On December 23, 2021, the U.S. HHS Assistant Secretary for Preparedness and Response confirmed sotrovimab appears to retain activity against the Omicron variant. 

And on January 11, 2022, the companies announced that the U.S. Government would purchase an additional 600,000 doses of sotrovimab to be delivered throughout the first quarter of 2022.