Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor-binding domain of the spike protein of SARS-CoV-2. The FDA has authorized the emergency use of bamlanivimab for the treatment of COVID-19 under an Emergency Use Authorization (EUA). " Based on a review of the topline data from the planned interim analysis of Trial J2W-MC-PYAB, also called BLAZE-1 (NCT04427501), an ongoing randomized, double-blind, placebo controlled, Phase 2 dose-finding trial of bamlanivimab monotherapy in outpatients with mild to moderate COVID-19, it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential...