AbCellera Biologics (ABCL) announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg administered with etesevimab (LY-CoV016) 1400 mg to include post-exposure prophylaxis (PEP) to prevent SARS-CoV-2 infection or symptomatic COVID-19. The neutralizing antibodies, which were authorized together by the FDA in February 2023 to treat early COVID-19 infection, can now also 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 use authorization for bamlanivimab together with etesevimab provides a way to protect the significant number of people who, because of their situational exposure risk or medical condition, remain vulnerable to COVID-19, more than 535,000 patients have been treated with bamlanivimab alone or together with etesevimab, potentially keeping more than 25,000 patients out of the hospital and saving more than 10,000 lives. With this expanded authorization, these antibodies, which have been shown to be effective against the highly contagious Delta variant, can now be used to protect some of the most at-risk people exposed to the virus.
Carl Hansen, Ph.D., CEO and President of AbCellera.
The expanded EUA is based on data from the Phase 3 BLAZE-2 trial that showed bamlanivimab prevented COVID-19 in nursing homes, reducing the risk of contracting the disease by up to 80 percent in nursing home residents and up to 57 percent among residents and staff of long-term care facilities. Eli Lilly and Company’s (Lilly) study was 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).
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 FDA, resumed the shipment and distribution of bamlanivimab and etesevimab administered together.
