Emergency Use Authorization for bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19.

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. This authorization follows the national reopening of distribution earlier this month.

"Despite very significant improvements to public health resulting from COVID-19 vaccination, with the rise of the highly contagious Delta variant, the virus continues to have a devastating impact on the most vulnerable individuals, including nursing home residents and individuals with medical conditions that put them at high risk for the most severe outcomes," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories. "We're pleased that this expansion will help us provide antibody therapies as post-exposure prophylaxis to help prevent the spread of COVID-19 to some of the most at-risk individuals in the U.S."

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, commonly referred to as nursing homes, across the U.S. In this placebo-controlled Phase III 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.