Monoclonal Antibody Therapy for COVID-19 Authorized for Pediatric Patients, Including Newborns

The FDA issued an emergency use authorization (EUA) of bamlanivimab and etesevimab—previously authorized for pediatric patients 12 year of age and older, weighing at least 40 kg (88 pounds)—to additionally authorize bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.

This revision also authorizes bamlanivimab and etesevimab to be administered together for postexposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.

A fact sheet for healthcare providers is available to provide important information about the emergency use of bamlanivimab and etesevimab, to be administered together, including dosing instructions, potential side effects, and drug interactions.

The EUA was issued to Eli Lilly and Company.

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