Bamlanivimab

Bamlanivimab (INN,[6] codenamed LY-CoV555) is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19.[7] The drug was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and 950,000 doses have been bought by the US government as of December 2020.[8]

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
  • CA: Authorized by interim order [2][3][4]
  • US: Unapproved (emergency use authorization)[5]
Identifiers
CAS Number
DrugBank
UNII
KEGG

The drug is an IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. The aim is to block viral attachment and entry into human cells, thus neutralizing the virus, and help preventing and treating COVID-19.[7]

Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.[7]

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.[9]

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.[10]

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

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.[11] 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.[12]

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 has been released yet.[13]

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.[14]

FDA authorization

In October 2020, Lilly submitted a request for an emergency use authorization (EUA) to the FDA.[7] 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.

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.[7]

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.[5] 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.[5] This includes those who are 65 years of age or older, or who have certain chronic medical conditions.[5]

References
  1. "What is bamlanivimab". Eli Lilly. Retrieved 16 December 2020.
  2. "Regulatory Decision Summary - Bamlanivimab". Health Canada. 20 November 2020. Retrieved 13 December 2020.
  3. "Bamlanivimab (bamlanivimab)". Health Canada. Retrieved 13 December 2020.
  4. "Bamlanivimab Product information". Health Canada. Retrieved 13 December 2020.
  5. "Coronavirus (COVID-19) Update: 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.
  6. 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.
  7. "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). October 28, 2020.
  8. "Lilly announces 650,000 additional doses of neutralizing antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19". Eli Lilly and Company (Press release). December 2, 2020.
  9. 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.
  10. 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.
  11. 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
  12. 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.
  13. Clinical trial number NCT04518410 for "ACTIV-2: A Study for Outpatients With COVID-19" at ClinicalTrials.gov
  14. "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.
  • "Bamlanivimab". Drug Information Portal. U.S. National Library of Medicine.
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