The Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab plus etesevimab for the treatment of mild to moderate COVID-19 in all 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.

The revision also authorizes the emergency use of bamlanivimab plus etesevimab for postexposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe disease, including hospitalization or death.

The expanded authorization was based on data from the phase 2/3 BLAZE-1 trial (ClinicalTrials.gov Identifier: NCT04427501), which evaluated the efficacy and safety of the monoclonal antibody therapy in 125 pediatric and infant patients who were at high risk for severe disease progression.

Results showed that the median time to complete symptom resolution was 7 days for patients treated with bamlanivimab 700mg and etesevimab 1400mg, and 5 days for patients treated with weight-based dosing of bamlanivimab plus etesevimab. The youngest participant was 10 months old and weighed 8.6kg.

None of the pediatric patients died or required hospitalization due to COVID-19. The safety profile in pediatric patients was found to be consistent with the previously established profile in adults.

“Children under 1 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,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “While today’s authorization includes postexposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination.”

For treatment of COVID-19, bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset. For postexposure prophylaxis, bamlanivimab and etesevimab should be given together as soon as possible following exposure to SARS-CoV-2.

The dosage in adults (18 years and older) and pediatric patients (less than 18 years and weighing at least 40kg) is bamlanivimab 700mg and etesevimab 1400mg administered together as a single intravenous infusion. The dosage for pediatric patients weighing less than 40kg will vary depending on body weight. Dosing guidance is available in the updated fact sheet. The recommended dosing regimen for patients weighing 12kg or less is predicted based on pharmacokinetic modeling and simulation.

References

  1. FDA expands authorization of two monoclonal antibodies for treatment and post-exposure prevention of COVID-19 to younger pediatric patients, including newborns. News release. US Food and Drug Administration. Accessed December 3, 2021. https://www.prnewswire.com/news-releases/fda-expands-authorization-of-two-monoclonal-antibodies-for-treatment-and-post-exposure-prevention-of-covid-19-to-younger-pediatric-patients-including-newborns-301437321.html.
  2. Lilly’s bamlanivimab with etesevimab authorized as the first and only neutralizing antibody therapy for emergency use in COVID-19 patients under the age of 12. News release. Eli Lilly and Company. Accessed December 3, 2021. https://www.prnewswire.com/news-releases/lillys-bamlanivimab-with-etesevimab-authorized-as-the-first-and-only-neutralizing-antibody-therapy-for-emergency-use-in-covid-19-patients-under-the-age-of-12-301437329.html