Bamlanivimab

Bamlanivimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Pronunciation/ˌbæmləˈnɪvɪmæb/ BAM-lə-NIV-i-mab[1]
Other namesLY-CoV555, LY3819253
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19.[8] The medication was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020,[9][10][11] and the EUA was revoked in April 2021.[12]

Bamlanivimab is an IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.[13] The aim is to block viral attachment and entry into human cells, thus neutralizing the virus, and help preventing and treating COVID-19.[8]

Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.[8]

Bamlanivimab is also used as part of the bamlanivimab/etesevimab combination that was granted an EUA by the FDA.[14][15][16]

In June 2021, the US Office of the Assistant Secretary for Preparedness and Response (ASPR) paused distribution of bamlanivimab and etesevimab together, and etesevimab alone (to pair with existing supply of bamlanivimab), due to the increase of circulating variants.[17][18][19]

  1. ^ "What is bamlanivimab". Eli Lilly. Retrieved 16 December 2020.
  2. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  3. ^ "Regulatory Decision Summary - Bamlanivimab". Health Canada. 20 November 2020. Retrieved 13 December 2020.
  4. ^ "Bamlanivimab (bamlanivimab)". Health Canada. 20 November 2020. Retrieved 13 December 2020.
  5. ^ "Bamlanivimab Product information". Health Canada. 25 April 2012. Retrieved 13 December 2020.
  6. ^ "Summary Basis of Decision (SBD) for Bamlanivimab". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  7. ^ "Bamlanivimab injection, solution". DailyMed. Retrieved 4 January 2022.
  8. ^ a b c "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" (Press release). Eli Lilly and Company. October 28, 2020.
  9. ^ "Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 18 March 2021.
  10. ^ "Emergency Use Authorization (EUA) for the Treatment of COVID-19". Eli Lilly and Company. 9 November 2020. Retrieved 18 March 2021.
  11. ^ Hinton DM (2 March 2021). "Emergency Use Authorization 090" (PDF). U.S. Food and Drug Administration.
  12. ^ "Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab". U.S. Food and Drug Administration (FDA) (Press release). 16 April 2021. Retrieved 16 April 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  13. ^ "Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs". Eli Lilly and Company. 7 October 2020. Retrieved 26 October 2020.
  14. ^ "Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab and Etesevimab" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 18 March 2021.
  15. ^ "Bamlanivimab and etesevimab EUA". Eli Lilly and Company. 9 February 2021. Retrieved 18 March 2021.
  16. ^ Hinton DM (16 September 2021). "Emergency Use Authorization 094" (PDF). U.S. Food and Drug Administration.
  17. ^ "Pause in the Distribution of bamlanivimab/etesevimab". U.S. Department of Health and Human Services. 25 June 2021.
  18. ^ "Important Update on the Distribution of Bamlanivimab/etesevimab". U.S. Department of Health and Human Services. 16 June 2021.
  19. ^ "Bamlanivimab and etesevimab Emergency Use Authorization (EUA) for COVID-19". Lilly COVID-19. Retrieved 2 July 2021.