Eli Lilly & Co.’s 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...

Eli Lilly & Co.’s 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 Dr. 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.

Monoclonal antibodies are lab-made molecules that mimic the natural antibodies produced by the immune system to ward off viruses. The antibodies attach to the virus, neutralizing it and preventing it from replicating in new cells.

The drugs differ from vaccines, which train the immune system to fight off the virus causing Covid-19, including the production of antibodies.

The FDA’s authorization is based on clinical trial data of pediatric and infant patients with mild to moderate Covid-19 symptoms who were at high risk for developing severe disease.

Lilly’s drug is a cocktail of two antibodies, bamlanivimab with etesevimab, that was first authorized for emergency use in February. Lilly said on Friday that more than 700,000 patients have been treated with the drug, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths.

Antibody drugs are administered via injection or infusion by a nurse or other healthcare professional.

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Doctors are increasingly turning to monoclonal-antibody drugs to treat high-risk patients who get sick with Covid-19. WSJ takes a look at how the therapies work and why they’re important for saving lives. Illustration: Jacob Reynolds/WSJ The Wall Street Journal Interactive Edition

Write to Joseph Walker at joseph.walker@wsj.com