By Joseph Walker
Eli Lilly & Co.’s /zigman2/quotes/200106384/composite LLY -0.82% monoclonal antibody drug has been cleared for emergency use in children under the age of 12, the Food and Drug Administration said on Friday.
The authorization is the first for an antibody drug to treat young children, including newborns, who have tested positive for COVID-19 or been exposed to the virus and who are at high risk of developing severe cases including hospitalization or death.
“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 of severe disease, said Cavazzoni. She emphasized, however, that antibody drug treatment isn’t a substitute for vaccination, which is authorized for children five years of age and up.
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