US gives emergency use approval for GSK-Vir Covid antibody drug

US gives emergency use approval for GSK-Vir Covid antibody drug

The drug will be used to treat mild-to-moderate infections in people aged 12 years and older.

WASHINGTON:
The US Food and Drug Administration gave an emergency use authorisation to the antibody treatment developed by Vir Biotechnology and GlaxoSmithKline for treating mild-to-moderate Covid-19 in people aged 12 years and older.

The antibody drug, Sotrovimab, is not authorised for patients who are hospitalised 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 and Eli Lilly have been authorised for emergency use in the US.

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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