FDA Updates EUA for Eli Lilly’s COVID-19 Antibody Cocktail to Include Young Children

The FDA has revised the Emergency Use Authorization (EUA) covering Eli Lilly’s COVID-19 antibody cocktail (bamlanivimab/etesevimab), enabling its use in children as young as babies with mild to moderate COVID-19 at high risk of progressing to severe disease.

The revised EUA was supported by positive results from a 125-participant trial in pediatric patients with at least one risk factor for severe COVID-19.

“Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.