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Bamlanivimab

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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
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

Bamlanivimab (INN,[7] codenamed LY-CoV555) is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19.[8] The drug was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020,[9][10][11] and 950,000 doses have been bought by the US government as of December 2020.[12]

The drug 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]

Studies

Bamlanivimab has been studied in several trials. While some initial results on bamlanivimab seemed promising, further results have not shown any clinically-relevant benefit.[13][17]

Animal trials

An initial trial tested bamlanivimab in rhesus monkeys. Administration of the drug reduced SARS-CoV-2 replications in the upper and lower respiratory tract of monkeys.[18]

Following these results in a non-human primate model, several human studies were initiated.

Human trials

BLAZE-1 Trial

The Blocking Viral Attachment and Cell Entry with SARS-CoV-2 Neutralizing Antibodies (BLAZE-1) trial was sponsored by the drug's developer Eli Lilly.[19] The drug was tested in SARS-CoV-2 patients who did not require hospitalization. While an interim analysis suggested reduced ER visits and hospitalizations, this difference was not statistically significant in the final analysis.[20]

ACTIV-2 Trial

This study is sponsored by the NIH, examining bamlanivimab administration to SARS-CoV-2 patients in the outpatient setting. The study is ongoing and no data have been released yet.[21]

ACTIV-3 Trial

This study was sponsored by the NIH, examining bamlanivimab administration to SARS-CoV-2 patients in the inpatient setting. The study was ended early due to futility.[22]

On 13 October 2020, the Phase II-III trial was paused due to safety concerns.[23][24][25]

On 26 October 2020, Eli Lilly announced that the National Institutes of Health (NIH) ACTIV-3 clinical trial evaluating its monoclonal antibody, bamlanivimab (LYCoV555), found that bamlanivimab was not effective in treating people hospitalized with COVID-19.[26] Other studies, including the NIH ACTIV-2 trial and its own BLAZE-1 trial, will continue to evaluate bamlanivimab.[26]

Authorization

On 7 October 2020, Eli Lilly and Company submitted a request for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for LY-CoV555 monotherapy in higher-risk people who have been diagnosed with mild-to-moderate COVID-19. This authorization was largely done on the basis of the interim BLAZE-1 results showing possible benefit. However, further data obtained after the EUA was granted have not shown any clinically-relevant benefit from bamlanivimab.[8][13]

On 9 November 2020, bamlanivimab was granted an emergency use authorization by the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID‑19 in adults and adolescents. Bamlanivimab is authorized for people with positive results of direct SARS‑CoV‑2 viral testing who are twelve years of age and older weighing at least 40 kilograms (88 lb), and who are at high risk for progressing to severe COVID‑19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.[6]

Bamlanivimab/etesevimab

Further information: Bamlanivimab/etesevimab

On 9 February 2021, the FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID‑19 in people twelve years of age or older weighing at least 40 kilograms (88 lb) who test positive for SARS‑CoV‑2 and who are at high risk for progressing to severe COVID‑19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.[27]

On 1 February 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started rolling reviews of data on the use of the monoclonal antibodies casirivimab/imdevimab, bamlanivimab/etesevimab, and bamlanivimab for the treatment of COVID‑19.[28]

Deployment

On 28 October 2020, Eli Lilly and Company announced that it had struck a deal with the US government to supply 300,000 vials of Bamlanivimab 700 mg for US$375 million.[8]

References

  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. Retrieved 13 December 2020.
  5. ^ "Bamlanivimab Product information". Health Canada. Retrieved 13 December 2020.
  6. ^ a b "FDA Authorizes Monoclonal Antibody for Treatment of COVID-19". U.S. Food and Drug Administration (FDA) (Press release). 9 November 2020. Retrieved 10 December 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ World Health Organization (2020). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition)" (PDF). WHO Drug Information. 34 (3): 645–6. Retrieved 23 November 2020.
  8. ^ a b c d e "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. ^ http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf
  12. ^ "Lilly announces 650,000 additional doses of neutralizing antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19" (Press release). Eli Lilly and Company. December 2, 2020.
  13. ^ a b c "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. ^ http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf
  17. ^ Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, et al. (January 2021). "SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19". The New England Journal of Medicine. 384 (3): 229–237. doi:10.1056/NEJMoa2029849. PMC 7646625. PMID 33113295.
  18. ^ Jones BE, Brown-Augsburger PL, Corbett KS, Westendorf K, Davies J, Cujec TP, et al. (October 2020). "LY-CoV555, a rapidly isolated potent neutralizing antibody, provides protection in a non-human primate model of SARS-CoV-2 infection". bioRxiv. doi:10.1101/2020.09.30.318972. PMC 7536866. PMID 33024963.
  19. ^ Clinical trial number NCT04427501 for "A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness" at ClinicalTrials.gov
  20. ^ Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, et al. (January 2021). "SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19". The New England Journal of Medicine. 384 (3): 229–237. doi:10.1056/NEJMoa2029849. PMC 7646625. PMID 33113295.
  21. ^ Clinical trial number NCT04518410 for "ACTIV-2: A Study for Outpatients With COVID-19" at ClinicalTrials.gov
  22. ^ "Statement—NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study | NIH: National Institute of Allergy and Infectious Diseases". www.niaid.nih.gov. Retrieved 2021-01-24.
  23. ^ Riley Griffin (13 October 2020). "Eli Lilly Covid Antibody Trial Paused Due to Safety Concerns". Bloomberg. Retrieved 13 October 2020.
  24. ^ "Eli Lilly's Antibody Trial Is Paused Over Potential Safety Concern". The New York Times. 13 October 2020. Retrieved 26 October 2020. {{cite news}}: Cite uses deprecated parameter |authors= (help)
  25. ^ "Lilly Statement on the NIAID Decision to Pause Enrollment in ACTIV-3 Clinical Trial". Eli Lilly and Company. 14 October 2020. Retrieved 26 October 2020.
  26. ^ a b "Lilly Statement Regarding NIH's ACTIV-3 Clinical Trial". Eli Lilly and Company (Press release). 26 October 2020. Retrieved 26 October 2020.
  27. ^ "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.
  28. ^ "EMA reviewing data on monoclonal antibody use for COVID-19" (Press release). European Medicines Agency (EMA). 4 February 2021. Retrieved 4 March 2021.

External links

  • "Bamlanivimab". Drug Information Portal. U.S. National Library of Medicine.
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