FDA Expands EUA for Lilly’s COVID-19 Monoclonal Antibody

The FDA has expanded Eli Lilly’s emergency use authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis.

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.

Lilly also announced an agreement for the U.S. government to purchase 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with about 200,000 doses expected to ship third quarter of 2021 and the remaining to be shipped in fourth quarter. This transaction is expected to generate about $330 million in revenue in the second half of 2021, according to a Lilly statement.

"The recent increase in COVID-19 cases has caused a substantial rise in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates," Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories, said in a statement. "Lilly developed bamlanivimab and etesevimab for administration together, in anticipation of variants such as the highly contagious Delta variant, which currently accounts for more than 98 percent of all identified COVID-19 cases in the United States."

The expanded authorization is based on data from BLAZE-2, a study conducted in partnership with the National Institute of Allergy and Infectious Diseases and the COVID-19 Prevention Network that enrolled residents and staff at long-term care facilities across the United States. In this placebo-controlled phase 3 study, bamlanivimab reduced the risk of contracting symptomatic COVID-19 by up to 80% in nursing home residents and up to 57% among residents and staff of long-term care facilities.

Bamlanivimab and etesevimab together are authorized for the treatment of mild-to-moderate COVID-19 in adults and adolescents (12 years of age) with positive results of direct SARS-CoV-2 viral testing. But the combination is not authorized for use in patient who are hospitalized or who need oxygen therapy.

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. It was designed to block viral attachment and entry into human cells. Etesevimab is a recombinant fully human monoclonal neutralizing antibody that specifically binds to the SARS-CoV-2 surface spike protein receptor and can block the binding of the virus to the ACE2 host cell surface receptor.