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Lilly’s Bamlanivimab and Etesevimab Gain EUA for Pediatric Use

Expanded authorization based on safety and efficacy in phase 2/3 BLAZE-1 trial in mild to moderate COVID-19 and high risk patients.

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By: Kristin Brooks

Managing Editor, Contract Pharma

The FDA expanded the Emergency Use Authorization for Lilly’s bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to <12 years old, as well as post-exposure prophylaxis.
 
The expanded authorization is based on safety and efficacy data of pediatric and infant patients in BLAZE-1, a phase 2/3 clinical trial studying bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 and who are at high risk for severe disease progression. The median time to complete symptom resolution as recorded in a trial specific daily symptom diary was 7 days for subjects treated with bamlanivimab 700 mg and etesevimab 1,400 mg and 5 days for subjects treated with weight-based dosing of bamlanivimab and etesevimab.
 
Bamlanivimab and etesevimab, when administered together, retain neutralization activity against the Delta variant, which is the predominant variant of concern in the U.S. Lilly has performed pseudovirus and authentic virus studies to confirm that bamlanivimab with etesevimab retain neutralization activity against the Delta variant. Lilly is working quickly to understand neutralization activity of its therapies on the Omicron variant.

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