Eli Lilly and Co. received expanded Emergency Use Authorization (EUA) from the FDA for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis (PEP) in certain individuals for the prevention of SARS-CoV-2 infection. The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison.
 
The expanded authorization is based on data from BLAZE-2, a study conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN), that enrolled residents and staff at long-term care facilities, across the U.S. In this placebo-controlled Phase 3 study, bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80 percent in nursing home residents and up to 57 percent among residents and staff of long-term care facilities.
 
Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to be granted emergency use authorization from the FDA as a treatment for mild to moderate COVID-19. Lilly now only supplies bamlanivimab and etesevimab together in the U.S.
 
Pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab together retain neutralization activity against the Alpha and Delta variants. On September 2nd, the Office of the Assistant Secretary for Preparedness and Response (ASPR), alongside the U.S. FDA, resumed the shipment and distribution of bamlanivimab and etesevimab administered together.
 
On September 15th, the Biden administration announced it will take over distribution to states of monoclonal antibody treatments for COVID, including Lilly’s bamlanivimab and etesevimab and Regneron’s casirivimab and imdevimab antibody cocktail, REGEN-COV.

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