FDA Expands EUA For Lilly's Bamlanivimab, Etesevimab To Include Post-exposure Prophylaxis For COVID

(RTTNews) - Eli Lilly and Company (LLY) Thursday said that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization for bamlanivimab and etesevimab administered together to include post-exposure prophylaxis 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 that enrolled residents and staff at long-term care facilities, across the U.S. In this placebo-controlled Phase 3 study, bamlanivimab 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.

BLAZE-2 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).