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 LLY bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to less than 12 years old. AbCellera Biologics Inc 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.