Antibody Treatment Now Includes Post-Exposure Prophylaxis for COVID-19

The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) 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 coronavirus infection, Eli Lilly and Company announced on September 16, 2021.

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

The neutralizing antibodies can be used together to treat high-risk individuals 12+ years of age who have not been fully vaccinated against COVID-19, or are not expected to mount an adequate immune response to complete COVID-19 vaccination, and have been exposed to the SARS-CoV-2 virus, or who are at high risk of exposure in institutional settings.

In a placebo-controlled Phase 3 study, bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80% in nursing home residents.

Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories, commented in a press release, "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."

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2.

And Etesevimab is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor.

Carl Hansen, Ph.D., CEO, and President of AbCellera, added, “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 are effective against the highly contagious Delta variant, can now be used to protect some of the most at-risk people exposed to the virus.”

Indianapolis, IN-based Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world.