This afternoon, the U.S. Food and Drug Administration expanded the Emergency Use Authorization for Eli Lilly’s monoclonal antibody treatment combination of bamlanivimab and etesevimab.
Children under the age of 12 battling infection from COVID-19 have a new option for treatment. This afternoon, the U.S. Food and Drug Administration expanded the Emergency Use Authorization for Eli Lilly’s monoclonal antibody treatment combination of bamlanivimab and etesevimab.
The expanded EUA allows bamlanivimab and etesevimab to be administered for high-risk pediatric patients from birth to 11 years old. This is the first monoclonal antibody that has been authorized in patients under the age of 12. The authorization comes as the country is seeing another wave of infections as more people are spending time together indoors during the holiday season. The expanded EUA allows for the administration of the monoclonal antibody treatment as a post-exposure prophylaxis.
Daniel Skovronsky, Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, said the EUA allows the company to expand its treatment and prevention capabilities to high risk individuals of any age.
“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,” Skovronsky said in a statement.
The FDA based its decision on data from BLAZE-1, a Phase II/III study of bamlanivimab and etesevimab assessing the monoclonal antibody combination for the treatment of mild to moderate COVID-19 in individuals who are at high risk for progression to serious disease symptoms. Eli Lilly said the average time for complete symptom resolution was seven days for a 700 mg dosing regimen of the treatment. It was five days with 1,400 mg for patients treated with weight-based dosing of bamlanivimab and etesevimab, the company noted.
For pediatric patients the clinical tests proved to be effective. No pediatric patient treated with the combination of bamlanivimab and etesevimab required hospitalization or saw their disease worsen and lead to death.
In its announcement this afternoon, Eli Lilly said the monoclonal antibody maintained its neutralization capabilities against the Delta variant, which is still the predominant variant of concern in the United States. With the arrival of the Omicron variant on the shores of the U.S., the Indianapolis-based company said it is assessing the neutralization capabilities of bamlanivimab and etesevimab for that viral strain.
Eli Lilly and its developmental partner AbCellera first won EUA in 2020 for bamlanivimab, a neutralizing IgG1 monoclonal antibody. However, that was later sidelined due to the rise of viral variants that diminished its effectiveness, such as the Delta variant. Following that, the companies developed a combination of bamlanivimab and etesevimab, which was authorized in February of this year for patients with mild-to-moderate COVID-19.
Bamlanivimab was first discovered by AbCellera from the blood of one of the first recovered COVID-19 patients in the United States. Lilly licensed etesevimab from Junshi Biosciences. Both bamlanivimab and etesevimab are neutralizing recombinant human IgG1 monoclonal antibodies, and both target the SARS-COV-2 spike protein receptor binding domain to prevent entry into human cells.
To date, Eli Lilly said more than 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab. The monoclonal antibodies have potentially prevented more than 35,000 hospitalizations and at least 14,000 deaths during the pandemic, the company added.
