USFDA expands EUA for Eli Lilly bamlanivimab with etesevimab
Indianapolis: Eli Lilly has recently announced that U.S. Food and Drug Administration (USFDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to <12 years old. This expansion allows for bamlanivimab and etesevimab to be administered together in high-risk pediatric patients for the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis.
"Our mission since the start of the pandemic has been to offer crucial support by developing therapeutic options that could prevent hospitalization and death for as many people as possible," said Daniel Skovronsky, M.D., Ph.D.,Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories. "With the FDA's decision to allow use of bamlanivimab with etesevimab in children and infants, Lilly can now offer treatment and prevention options to high-risk individuals of any age."
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. No pediatric subject died or required hospitalization due to COVID-19.
Bamlanivimab and etesevimab, when administered together, retain neutralization activity against the Delta variant, which is the predominant variant of concern within the U.S.
"Lilly has performed pseudovirus and authentic virus studies to confirm that bamlanivimab with etesevimab retain neutralization activity against the Delta variant of concern. Lilly is working quickly to understand neutralization activity of our therapies on the Omicron variant of concern,"
To date, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst of the pandemic.