The Food and Drug Administration (FDA) has 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 at least one Years of age are at high risk of progression to severe COVID-19, including hospitalization or death.
The revision also approves the emergency use of bamlanivimab plus etesevimab for post-exposure prophylaxis for the prevention of COVID-19 in all pediatric patients, including newborns, who are at high risk of progression to serious illness, including hospitalization or death.
The expanded approval was based on data from the Phase 2/3 BLAZE-1 study (ClinicalTrials.gov Identifier: NCT04427501), which determined the efficacy and safety of monoclonal antibody therapy in 125 pediatric and infant patients at high risk for severe disease progression.
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Results showed that the median time to complete resolution of symptoms was 7 days in patients treated with 700 mg bamlanivimab and 1400 mg etesevimab and 5 days in patients treated with weight-based dosing of bamlanivimab plus etesevimab . The youngest participant was 10 months old and weighed 8.6 kg.
None of the pediatric patients died or had to be hospitalized due to COVID-19. The safety profile in pediatric patients was found to be the same as that previously established in adults.
“Children under 1 year of age exposed to the virus that causes COVID-19 may be at particularly high risk of severe COVID-19, and this approval addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, MD, Director of the FDA’s Center for Drug Evaluation and Research. “Although today’s approval includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination.”
For the treatment of COVID-19, bamlanivimab and etesevimab should be co-administered as soon as possible after positive results from a direct SARS-CoV-2 virus test and within 10 days of the onset of symptoms. For post-exposure prophylaxis, bamlanivimab and etesevimab should be given together as soon as possible after exposure to SARS-CoV-2.
The dosage in adults (18 years of age and older) and pediatric patients (under 18 years of age and weighing at least 40 kg) is 700 mg bamlanivimab and 1400 mg etesevimab, given together as a single intravenous infusion. The dosage for pediatric patients weighing less than 40 kg depends on body weight. Please refer to the updated data sheet for dosing instructions. The recommended dosage regimen for patients weighing 12 kg or less is predicted based on pharmacokinetic models and simulations.
References
- The FDA is expanding approval of two monoclonal antibodies for the treatment and prevention of COVID-19 to younger pediatric patients, including newborns. Press release. U.S. Food and Drug Administration. Accessed December 3, 2021. https://www.prnewswire.com/news-releases/fda-expands-authorization-of-two-monoclonale-antibodies-for-treatment-and-post-exposure-prevention-of-covid – 19-to-younger-pediatric-patients-including-neonates-301437321.html.
- Lillys Bamlanivimab with Etesevimab approved as the first and only neutralizing antibody therapy for emergency use in COVID-19 patients under 12 years of age. Press 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.
This article originally appeared on MPR
