Eli Lilly Stops Distribution of Bamlanivimab as COVID-19 Treatment

The US government in coordination with Eli Lilly said it will no longer distribute the COVID-19 monoclonal antibody therapy bamlanivimab for use on its own.

Given the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company, stopped the distribution of bamlanivimab on March 24, 2021.

The U.S. Food and Drug Administration (FDA) recently updated the authorized Fact Sheet for Healthcare Providers for the bamlanivimab Emergency Use Authorization (EUA). This update advised healthcare providers to consider the use of alternative authorized monoclonal antibody therapies that are expected to retain activity against circulating viral variants. Using an alternative authorized monoclonal antibody therapy may reduce the risk of treatment failure should a patient be infected with a SARS-CoV-2 viral variant that is resistant to bamlanivimab alone. Alternative monoclonal antibody therapies that are currently authorized for the same use include bamlanivimab and etesevimab administered together and REGEN-COV.

Health care providers should review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under an EUA for details regarding specific variants and resistance. Health care providers should also refer to the Centers for Disease Control and Prevention (CDC) website and information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

All treatment delivery sites will continue to be able to order bamlanivimab and etesevimab, to be administered together, or REGEN-COV from the authorized distributer following existing ordering and reporting procedures. Additionally, sites can order etesevimab alone to pair with the current supply of bamlanivimab the site has available. Monoclonal antibody therapies available under an EUA must be used in accordance with the terms and conditions for the respective authorization.

ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use.