FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns

For immediate release: December 3, 2021

Today, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) of bamlanivimab and etesevimab (previously approved for pediatric patients 12 years of age and older weighing at least 40 kilograms, or approximately 88 pounds) to also include bamlanivimab and etesivimab co-administered for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including neonates, who have a positive COVID-19 test and are at high risk of progression to severe COVID-19, including hospitalization or death. This revision also allows bamlanivimab and etesevimab, co-administered, for post-exposure prophylaxis to prevent COVID-19 in all pediatric patients, including neonates, at high risk of progression to severe COVID-19, including hospitalization or death.

“Now all patients at high risk for severe COVID-19, including children and newborn infants, have a post-exposure treatment and prevention option. Children under one year of age exposed to the virus that causes COVID-19 may have a particularly high risk of severe COVID-19 and this authorization is addressing the medical needs of this vulnerable population,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. -19 in children post-exposure, this therapeutic option is not a substitute for vaccination. Vaccines remain our best tool in the fight against the virus and a COVID-19 vaccine has been approved for children 5 years and older.”

Monoclonal antibodies are lab-made proteins that mimic the immune system’s ability to fight off harmful pathogens, such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies specifically directed against the SARS-CoV-2 spike protein, designed to block virus attachment and access to human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the virus spike protein.

In February, the FDA originally approved the co-administration of bamlanivimab and etesevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg) with positive immediate results. SARS-CoV-2 viral tests, and who are at high risk of progressing to severe COVID-19 and/or hospitalization. In September, the agency approved its use for post-exposure prevention of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID-19, including hospitalization or death.

To support today’s action, bamlanivimab and etesevimab, administered together, were studied in a clinical trial of 125 pediatric patients (14 adolescent patients received placebo), all with at least one risk factor for severe COVID-19, to determine safety and pharmacokinetics. of treatment in pediatric patients. Patients weighing less than 40 kg received body weight-adjusted doses of bamlanivimab and etesevimab to achieve comparable exposures to adults and adolescents receiving the authorized dose. Given the similar course of COVID-19 disease, the approval of bamlanivimab and etesevimab in younger pediatric patients, including neonates, is supported by safety and efficacy data in adolescents and adults, along with additional pharmacokinetic and safety data from the pediatric clinical trial. patients .

Serious adverse reactions, including hypersensitivity, anaphylaxis and infusion-related reactions, have been observed with bamlanivimab with and without co-administration of etesevimab. Possible side effects of co-administered bamlanivimab and etesevimab include nausea, dizziness, itching and rash.

The FDA is working with sponsors of all currently authorized therapies to assess activity against each SARS-CoV-2 variant(s) of interest worldwide and is committed to communicating with the public as we learn more.

Under the EUA, fact sheets containing important information on the emergency use of bamlanivimab and etesevimab, to be administered together, must be made available to healthcare professionals and to patients, parents and carers. These fact sheets contain dosing instructions, possible side effects and drug interactions.

The EUA was issued to Eli Lilly and Co.

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The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.

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