The FDA issued an emergency use authorization (EUA) on February 9, 2021, for monoclonal antibodies bamlanivimab and etesevimab administered together for mild to moderate COVID-19 treatment in adults and children age 12 years or older weighing at least 88 pounds who test positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19.
Monoclonal antibodies are laboratory-made proteins able to fight off viruses by imitating the immune system. Bamlanivimab and etesevimab attack the spike protein of SARS-CoV-2, blocking the virus' attachment and entry into human cells.
EUA was based on results of a clinical trial of 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19, in which a single I.V. infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death compared with placebo.
Scientists are still evaluating the safety and efficacy of this treatment. Bamlanivimab...