Bamlanivimab

Bamlanivimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Names
Pronunciation/ˌbæmləˈnɪvɪmæb/ BAM-lə-NIV-i-mab[1]
Other namesLY-CoV555, LY3819253
Clinical data
Main usesCOVID-19[2]
Side effectsNausea, dizziness, headache[2]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Intravenous
Typical dose700 mg[3]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
  • CA: Rx-only; Authorized by interim order [4][5][6]

Bamlanivimab is medication used to treat COVID-19; however COVID variants including Omicron have developed resistance.[2][7][8][8] While no longer used alone, it continues to be used as part of the combination bamlanivimab/etesevimab.[9] It is given by injection into a vein.[2]

Common side effects include nausea, dizziness, and headache.[2] Other side effects may include anaphylaxis.[2] While safety in pregnancy is unclear, it may be used in pregnancy.[2] It is a monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.[7]

Bamlanivimab received emergency use authorization (EUA) in the United States in November 2020.[2][10] In April 2021, the EUA was revoked for use alone.[11] The combination remains in use as of December 2021 in certain areas with low resistance.[3] It is not approved in either Europe or the United Kingdom.[12] The United States government paid about 1,250 USD per dose in 2020.[13]

Medical uses

It is has been used in mild to moderate COVID-19, which does not require hospitalization, but who are at high risk of severe disease.[3] As of December 2021 use is only recommended in certain areas were resistance is low and in combination with etesevimab.[3]

Dosage

It is given as a single dose of 700 mg together with 1,400 mg of etesevimab.[3]

Mechanism of action

The aim is to block viral attachment and entry into human cells, thus neutralizing the virus, and help preventing and treating COVID-19.[14]

History

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.[14][15]

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.[16]

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 in adults and certain pediatric patients.[11]

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.[17]

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.[18]

Society and culture

Names

Bamlanivimab is the international nonproprietary name (INN).[19]

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.[14]

The US government bought 950,000 doses as of December 2020.[20]

Research

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".[21] However, further results have not shown any clinically-relevant benefit.[15][22]

BLAZE-1

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.[24] A subsequent analysis demonstrated superior efficacy of a combination of bamlanivimab and etesevimab compared to placebo.[25]

ACTIV-2

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.[26]

ACTIV-3

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.[27][28]

References

  1. ↑ "What is bamlanivimab". Eli Lilly. Archived from the original on 28 December 2020. Retrieved 16 December 2020.
  2. 1 2 3 4 5 6 7 8 "Bamlanivimab Monograph for Professionals". Drugs.com. Archived from the original on 17 September 2021. Retrieved 8 January 2022.
  3. 1 2 3 4 5 "Anti-SARS-CoV-2 Monoclonal Antibodies". COVID-19 Treatment Guidelines. Archived from the original on 8 January 2022. Retrieved 8 January 2022.
  4. ↑ "Regulatory Decision Summary - Bamlanivimab". Health Canada. 20 November 2020. Archived from the original on 16 January 2021. Retrieved 13 December 2020.
  5. ↑ "Bamlanivimab (bamlanivimab)". Health Canada. Archived from the original on 11 January 2021. Retrieved 13 December 2020.
  6. ↑ "Bamlanivimab Product information". Health Canada. 25 April 2012. Archived from the original on 16 January 2021. Retrieved 13 December 2020.
  7. 1 2 "Bamlanivimab - Potential Risk of Treatment Failure Due to Circulation of Resistant SARS-CoV-2 Variants". recalls-rappels.canada.ca. 28 October 2021. Archived from the original on 8 January 2022. Retrieved 8 January 2022.
  8. 1 2 "Statement on Therapies for High-Risk, Nonhospitalized Patients". COVID-19 Treatment Guidelines. Archived from the original on 7 January 2022. Retrieved 6 January 2022.
  9. ↑ "Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab and Etesevimab" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on 18 March 2021. Retrieved 18 March 2021.
  10. ↑ "Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on 17 March 2021. Retrieved 18 March 2021.
  11. 1 2 "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. Archived from the original on 16 April 2021. Retrieved 16 April 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  12. ↑ "Bamlanivimab". SPS - Specialist Pharmacy Service. 11 February 2021. Archived from the original on 19 November 2021. Retrieved 8 January 2022.
  13. ↑ "Promising new therapy for COVID-19 cleared by U.S., still under review by Health Canada". CBC. Archived from the original on 4 September 2021. Retrieved 8 January 2022.
  14. 1 2 3 "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. Archived from the original on December 28, 2020. Retrieved October 13, 2021.
  15. 1 2 "Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs". Eli Lilly and Company. 7 October 2020. Archived from the original on 27 October 2020. Retrieved 26 October 2020.
  16. ↑ "FDA Authorizes Monoclonal Antibody for Treatment of COVID-19". U.S. Food and Drug Administration (FDA) (Press release). 9 November 2020. Archived from the original on 11 January 2021. Retrieved 10 December 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  17. ↑ "FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19". U.S. Food and Drug Administration (FDA) (Press release). 10 February 2021. Archived from the original on 10 February 2021. Retrieved 9 February 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  18. ↑ "EMA reviewing data on monoclonal antibody use for COVID-19" (Press release). European Medicines Agency (EMA). 4 February 2021. Archived from the original on 15 March 2021. Retrieved 4 March 2021.
  19. ↑ 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. Archived (PDF) from the original on 27 November 2020. Retrieved 23 November 2020.
  20. ↑ "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. Archived from the original on December 29, 2020. Retrieved October 13, 2021.
  21. ↑ 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.
  22. ↑ 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.
  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. ↑ 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.
  25. ↑ 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. Archived from the original on 2021-10-19. Retrieved 2021-10-13.
  26. ↑ Clinical trial number NCT04518410 for "ACTIV-2: A Study for Outpatients With COVID-19" at ClinicalTrials.gov
  27. ↑ "Statement—NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study | NIH: National Institute of Allergy and Infectious Diseases". www.niaid.nih.gov. Archived from the original on 2021-01-23. Retrieved 2021-01-24.
  28. ↑ 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.
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