FDA authorizes Lilly antibody treatment for use in children, including newborns

The Food and Drug Administration (FDA) on Friday expanded the emergency authorization of Eli Lilly’s antibody therapy for treating mild to moderate COVID-19 symptoms to include all children, including newborns.

The treatment is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together through intravenous infusion. It was previously authorized for pediatric patients 12 years of age and older weighing at least 88 pounds.

The treatment is now authorized for all pediatric patients who have a positive COVID-19 test or who have been exposed to someone with COVID-19, who are at high risk for progression to severe COVID-19, including hospitalization or death. 

The treatment was initially authorized in February and has been used in more than 700,000 patients.

“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “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.”

The therapy, however, is not a substitute for vaccination, Cavazzoni said.

The expanded authorization comes amid questions over the effectiveness of the treatment against the newly-emerged omicron variant. Lilly said it is working quickly to study the impact. Initial reports from South Africa, which first warned the world about the variant, show increasing infections in children under five, though scientists stress that everything known right now is preliminary.

All the major vaccine companies are also working to determine if their vaccines are effective against omicron.