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Bamlanivimab and etesevimab FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 17, 2021.

FDA Approved: No (Emergency Use Authorization)
Generic name: bamlanivimab and etesevimab
Dosage form: Intravenous Infusion
Company: Eli Lilly and Company
Treatment for: COVID-19, Post-Exposure Prophylaxis of COVID-19

Bamlanivimab and etesevimab are two monoclonal antibodies administered together to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.

  • Treatment of Mild to Moderate COVID-19 On February 9, 2021, the bamlanivimab and etesevimab combination received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
  • Post-Exposure Prophylaxis of COVID-19 On September 16, 2021, the bamlanivimab and etesevimab combination received Emergency Use Authorization (EUA) from the FDA for post-exposure prophylaxis of COVID-19 in treat high-risk adults and pediatric individuals (12 years of age or older weighing at least 40 kg) 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.
  • Bamlanivimab and etesevimab together have not been approved by the FDA for any use. Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Bamlanivimab and etesevimab together are not authorized for pre-exposure prophylaxis for prevention of COVID-19.
  • There are limited clinical data available for bamlanivimab and etesevimab together. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together.
  • Bamlanivimab and etesevimab are administered at the same time via intravenous infusion over a period of 21 – 60 minutes or longer.
  • Possible side effects of bamlanivimab and etesevimab include allergic reactions, worsening of COVID-19 symptoms, pain at the infusion site, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

Development timeline for bamlanivimab and etesevimab

DateArticle
Jan 24, 2022Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
Dec  3, 2021Lilly's Bamlanivimab with Etesevimab Authorized as the First and Only Neutralizing Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12
Sep 16, 2021Emergency Use Authorization for Lilly's Bamlanivimab and Etesevimab Administered Together Expanded to Include Post-Exposure Prophylaxis for COVID-19
Sep 15, 2021Lilly to Supply 388,000 Doses of Etesevimab to U.S. Government for Treatment of COVID-19
Mar 10, 2021Lilly's Bamlanivimab and Etesevimab Together Reduced Hospitalizations and Death in Phase 3 Trial for Early COVID-19
Feb 26, 2021Lilly Announces Additional Doses of Neutralizing Antibody Therapy Purchased by U.S. Government to Treat COVID-19
Feb  9, 2021Lilly's Bamlanivimab (LY-CoV555) Administered with Etesevimab (LY-CoV016) Receives FDA Emergency Use Authorization for COVID-19
Jan 26, 2021New Data Show Treatment with Lilly's Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

See also

bamlanivimab and etesevimab Consumer information

Further information

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