Benzinga | Dec 6, 2021 08:03AM EST

Lilly's COVID-19 Antibody Cocktail Scores FDA Emergency Use For Kids, Including Newborns

The FDA has expanded the Emergency Use Authorization (EUA) for Eli Lilly And Co's (NYSE:LLY) bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to less than 12 years old. AbCellera Biologics Inc (NASDAQ:ABCL) discovered the antibody cocktail.

* The 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.

* Related: AbCellera Stock Is Moving Higher After Expanded Use Nod For Lilly-Partnered COVID-19 Antibody.

* The expanded authorization is based on the safety and efficacy data in the BLAZE-1 Phase 2/3 trial.

* 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.

* No pediatric subject died or required hospitalization due to COVID-19.

* IN November, Eli Lilly announced an additional purchase by the U.S. government to supply 614,000 doses of bamlanivimab with etesevimab for $1.29 billion.

* The new purchase will add $840 million of revenue and approximately $0.25 of additional EPS beyond the guidance issued during its most recent financial results.

* Price Action: LLY shares traded 0.35% higher at $246.45, and ABCL shares are up 1.07% at $14.17 during the premarket session on the last check Monday.