Bamlanivimab/etesevimab

Bamlanivimab/etesevimab
Combination of
BamlanivimabMonoclonal antibody
EtesevimabMonoclonal antibody
Clinical data
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status

Bamlanivimab/etesevimab is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together via intravenous infusion as a treatment for COVID-19.[3][6][7][8] Both types of antibody target the surface spike protein of SARS‑CoV‑2.[9][10]

Bamlanivimab and etesevimab, administered together, are authorized in the United States for the treatment of mild-to-moderate COVID-19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb) 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.[4][5] They are also authorized, when administered together, for use after exposure to the SARS-CoV-2 virus for post-exposure prophylaxis (PEP) for COVID-19 and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus.[4][5]

In January 2022, the U.S. Food and Drug Administration (FDA) revised the authorizations for two monoclonal antibody treatments – bamlanivimab/etesevimab (administered together) and casirivimab/imdevimab – to limit their use to only when the recipients are likely to have been infected with or exposed to a variant that is susceptible to these treatments.[11] Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.[11]

  1. ^ "Bamlanivimab injection, solution". DailyMed. Retrieved 4 January 2022.
  2. ^ "Etesevimab injection, solution". DailyMed. Retrieved 4 January 2022.
  3. ^ a b "FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19". U.S. Food and Drug Administration (FDA) (Press release). 10 February 2021. Retrieved 9 February 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ a b c "FDA authorizes bamlanivimab and etesevimab for COVID-19". U.S. Food and Drug Administration (FDA). 16 September 2021. Retrieved 16 September 2021.
  5. ^ a b c "Emergency Use Authorization 094" (PDF). U.S. Food and Drug Administration (FDA). 16 September 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ "Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19" (Press release). Eli Lilly and Company. 9 February 2021. Retrieved 9 February 2021 – via PR Newswire.
  7. ^ "New 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" (Press release). Eli Lilly and Company. 26 January 2021. Retrieved 9 February 2021 – via PR Newswire.
  8. ^ Hurt AC, Wheatley AK (April 2021). "Neutralizing Antibody Therapeutics for COVID-19". Viruses. 13 (4): 628. doi:10.3390/v13040628. PMC 8067572. PMID 33916927.
  9. ^ Cite error: The named reference Guide was invoked but never defined (see the help page).
  10. ^ "Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19". Eli Lilly and Company (Press release). 28 October 2020.
  11. ^ a b "Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant" (Press release). U.S. Food and Drug Administration (FDA). 24 January 2022. Retrieved 24 January 2022. Public Domain This article incorporates text from this source, which is in the public domain.