On May 26, 2021, the U.S. FDA issued an emergency use authorization (EUA) for sotrovimab, an investigational monoclonal antibody treatment for mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms). The drug is authorized for use in patients who have tested positive for SARS-CoV-2 and who are at high risk for progression to severe COVID-19, including hospitalization or death; for example, patients age 65 years or older or with certain medical conditions.

This therapy is not authorized for patients who have been hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19; monoclonal antibodies may be associated with worse clinical outcomes in this patient population.

Monoclonal antibodies are proteins designed in the lab that copy the immune system's capabilities of fighting off antigens such as viruses. Sotrovimab is designed to protect against the spike protein of SARS-CoV-2....

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