February 10, 2021 -- The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) to Eli Lilly for the combination of the monoclonal antibodies (mAbs) bamlanivimab and etesevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients ages 12 and older.
The treatment is designated for patients who are at high risk for progressing to severe COVID-19, including individuals ages 65 or older who have certain chronic medical conditions. The combination of bamlanivimab and etesevimab is not authorized for hospitalized patients or those who require oxygen therapy due to COVID-19.
The EUA is based on a clinical trial where a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared with the placebo. Hospitalization or death occurred in 36 (7%) patients who received placebo, compared with 11 (2%) patients treated with bamlanivimab and etesevimab together. The safety and effectiveness of the combination therapy continues to be evaluated.
Bamlanivimab and etesevimab are mAbs that are specifically directed against the spike protein of SARS-CoV-2 and designed to block the virus's attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus. The authorized dosage of the combination therapy is 700 mg of bamlanivimab and 1,400 mg of etesevimab.