View of the headquarters of the British pharmaceutical company GlaxoSmithKline in west London.
Ben Stansall | AFP | Getty Images
The U.S. Food and Drug Administration gave an emergency use authorization 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 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.
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.