AbCellera-Lilly Combo Authorized as 1st/Only Antibody for Emergency Use in Under-12s

 AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include pediatric patients under the age of 12, including neonates (infants <1 year old). The EUA allows for bamlanivimab and etesevimab administered together in the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis in certain patients.

The expanded EUA is based on data from the BLAZE-1 Phase 2/3 clinical trial studying bamlanivimab and etesevimab administered together for the treatment of pediatric and infant patients with 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 subject died or required hospitalization due to COVID-19.

Pseudovirus and authentic virus studies conducted by AbCellera’s partner, Eli Lilly and Company (Lilly), demonstrate that bamlanivimab and etesevimab together retain neutralization activity against the Delta variant, which is currently the predominant variant of concern within the U.S.

https://www.biospace.com/article/releases/abcellera-discovered-bamlanivimab-together-with-etesevimab-authorized-as-the-first-and-only-antibody-therapy-for-emergency-use-in-covid-19-patients-under-the-age-of-12/