US FDA Gives Emergency Use Approval for GSK-Vir COVID-19 Antibody Drug

Reuters Staff

May 27, 2021

The U.S. Food and Drug Administration gave an emergency use authorization to the antibody treatment developed by Vir Biotechnology (VIR.O) and GlaxoSmithKline (GSK.L) for treating mild-to-moderate COVID-19 in people aged 12 years and older.

The antibody drug, Sotrovimab, is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy, the health regulator said on Wednesday.

Sotrovimab belongs to a class of drugs called monoclonal antibodies, which mimic natural antibodies that the body generates to fight off infection.

The antibody treatment will be available for COVID-19 patients in the coming weeks, GSK and Vir said, adding that they plan to submit a marketing application to the FDA in the second half of 2021.

Similar COVID-19 therapies by Regeneron Pharmaceuticals (REGN.O) and Eli Lilly (LLY.N) have been authorized for emergency use in the United States.

The European Union's drug regulator last week backed the use of Sotrovimab for COVID-19 patients who were at risk of severe disease and do not need supplemental oxygen.

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