September 16, 2021

The U.S. FDA has expanded the emergency use authorization (EUA) for Eli Lilly’s investigation drugs bamlanivimab and etesevimab. These medications can now be administered together to prevent COVID-19 following exposure to the SARS-CoV-2 virus.

  • Under the EUA, the drugs can be used for post-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (at least 12 years old and weighing at least 40kg, or 88 pounds) who meet the following criteria:
    • Are at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated or are not expected to have an adequate immune response to complete COVID-19 vaccination; and
      • Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC); or
      • Are at high risk of exposure to an individual infected with SARS-CoV-2 because of SARS-CoV-2 infection in other individuals in the same institutional setting, such as a nursing home or prison.
    • The FDA has emphasized that post-exposure prophylaxis is not a substitute for vaccination against COVID-19.
    • Bamlanivimab and etesevimab are also authorized for use together in the treatment of mild to moderate COVID-19 in adults and adolescents (at least 12 years old and weighing at least 40kg) who are at high risk of severe COVID-19, including hospitalization or death.
    • The drugs can only be used in states, territories, and U.S. jurisdictions in which the combined frequency of SARS-CoV-2 variants resistant to bamlanivimab and etesevimab does not exceed 5%. The FDA provides a current list of these areas on its website.
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