Wikipedia

Bamlanivimab

(Redirected from LY-CoV555)

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emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020,[9][10][11] and the EUA was revoked in April 2021.[12]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
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 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]

Studies

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Bamlanivimab has been studied in several trials. Some initial results on bamlanivimab seemed promising, with one review saying that it "decrease[s] viral load when given early on in the course of SARS-CoV-2 infection and favourably impact[s] clinical outcomes for patients with mild-to-moderate COVID-19".[20] However, further results have not shown any clinically relevant benefit.[13][21]

Animal trials

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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.[22]

Human trials

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BLAZE-1 Trial

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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.[23] 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.[21] A subsequent analysis demonstrated superior efficacy of a combination of bamlanivimab and etesevimab compared to placebo.[24]

ACTIV-2 Trial

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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.[25]

ACTIV-3 Trial

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This study specifically examined bamlanivimab in hospitalized COVID-19 patients without severe illness (e.g. end organ damage); these patients were also receiving the standard of care at the time including supportive care, remdesivir, supplemental oxygen, and dexamethasone as indicated. Enrollment was stopped early due to futility; bamlanivimab was not found to increase sustained recovery (90 days), and did not change pulmonary function. The study was funded by Operation Warp Speed.[26][27]

Authorization

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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 or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.[28]

On 16 April 2021, the FDA revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19.[12]

Bamlanivimab/etesevimab

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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.[29]

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.[30] On 29 October 2021, Eli Lilly withdrew bamlanivimab and etesevimab from the European Medicines Agency rolling review process.[31]

Deployment

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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]

Society and culture

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Names

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Bamlanivimab is the international nonproprietary name (INN).[32]

References

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  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 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. ^ Hinton DM (2 March 2021). "Emergency Use Authorization 090" (PDF). U.S. Food and Drug Administration.
  12. ^ a b "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.   This article incorporates text from this source, which is in the public domain.
  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. ^ 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.
  20. ^ Taylor PC, Adams AC, Hufford MM, de la Torre I, Winthrop K, Gottlieb RL (June 2021). "Neutralizing monoclonal antibodies for treatment of COVID-19". Nature Reviews. Immunology. 21 (6): 382–393. doi:10.1038/s41577-021-00542-x. PMC 8054133. PMID 33875867.
  21. ^ a b 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. ISSN 0028-4793. PMC 7646625. PMID 33113295.
  22. ^ 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.
  23. ^ 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
  24. ^ Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P, et al. (October 2021). "Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19". The New England Journal of Medicine. 385 (15): 1382–1392. doi:10.1056/NEJMoa2102685. PMC 8314785. PMID 34260849.
  25. ^ Clinical trial number NCT04518410 for "ACTIV-2: A Study for Outpatients With COVID-19" at ClinicalTrials.gov
  26. ^ "Statement – NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study | NIH: National Institute of Allergy and Infectious Diseases". www.niaid.nih.gov. 26 October 2020. Retrieved 2021-01-24.
  27. ^ Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, et al. (March 2021). "A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19". The New England Journal of Medicine. 384 (10): 905–914. doi:10.1056/NEJMoa2033130. PMC 7781100. PMID 33356051.
  28. ^ "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.   This article incorporates text from this source, which is in the public domain.
  29. ^ "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.   This article incorporates text from this source, which is in the public domain.
  30. ^ "EMA reviewing data on monoclonal antibody use for COVID-19" (Press release). European Medicines Agency (EMA). 4 February 2021. Retrieved 4 March 2021.
  31. ^ "Bamlanivimab and etesevimab for COVID-19: Withdrawn application". European Medicines Agency (EMA) (Press release). 2 November 2021. Retrieved 24 April 2022.
  32. ^ 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): 645–646. Retrieved 23 November 2020.
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