Menu
Home Explore People Places Arts History Plants & Animals Science Life & Culture Technology
On this page
Bamlanivimab/etesevimab
Monoclonal antibody combination treatment for COVID-19

Bamlanivimab and etesevimab are two monoclonal antibodies administered together via intravenous infusion to treat COVID-19 by targeting the surface spike protein of SARS-CoV-2. Authorized in the U.S. for mild-to-moderate COVID-19 in patients aged 12 and older at high risk of severe disease, they are also used for post-exposure prophylaxis. However, as of January 2022, the FDA limits their use due to reduced effectiveness against the widely circulating omicron variant, rendering them currently unauthorized across the United States.

We don't have any images related to Bamlanivimab/etesevimab yet.
We don't have any YouTube videos related to Bamlanivimab/etesevimab yet.
We don't have any PDF documents related to Bamlanivimab/etesevimab yet.
We don't have any Books related to Bamlanivimab/etesevimab yet.
We don't have any archived web articles related to Bamlanivimab/etesevimab yet.

Contents

Etesevimab

Etesevimab is a monoclonal antibody against the surface spike protein of SARS‑CoV‑2.1314

Eli Lilly licensed etesevimab from Junshi Biosciences.15

Bamlanivimab

Main article: Bamlanivimab

Bamlanivimab 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-19.16

Trials

The data supporting the emergency use authorization (EUA) for bamlanivimab and etesevimab are based on a randomized, double-blind, placebo-controlled clinical trial in 1,035 non-hospitalized participants with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19.17 Of these participants, 518 received a single infusion of bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams together, and 517 received placebo.18 The primary endpoint was COVID-19 related hospitalizations or death by any cause during 29 days of follow-up.19 Hospitalization or death occurred in 36 (7%) participants who received placebo compared to 11 (2%) participants treated with bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams administered together, a 70% reduction.20 All ten deaths (2%) occurred in the placebo group.21 Thus, all-cause death was significantly lower in the bamlanivimab 2,800-milligram and etesevimab 2,800-milligram group than the placebo group.22

Economics

In February 2021, the United States government agreed to purchase 100,000 doses of the drug for $210 million, at $2,100 per dose.23

Research

COVID-19

In 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-19.2425 The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. While bamlanivimab and etesevimab administered together resulted in a lower risk of resistant viruses developing during treatment compared with bamlanivimab administered alone, both treatments are available under an EUA and are expected to benefit people at high risk of disease progression.26 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.27 The EUA was issued to Eli Lilly and Co.28

In 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-19.29 In March 2021, the CHMP concluded that bamlanivimab and etesevimab can be used together to treat confirmed COVID-19 in people who do not require supplemental oxygen and who are at high risk of their COVID-19 disease becoming severe.30 The CHMP also looked at the use of bamlanivimab alone and concluded that, despite uncertainties around the benefits of monotherapy, it can be considered a treatment option.31 In October 2021, the CHMP ended the rolling review of bamlanivimab/etesevimab.3233

 This article incorporates public domain material from the United States Department of Health and Human Services

References

  1. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  2. "Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19" (Press release). Eli Lilly and Company. 9 February 2021. Retrieved 9 February 2021 – via PR Newswire. https://www.prnewswire.com/news-releases/lillys-bamlanivimab-ly-cov555-administered-with-etesevimab-ly-cov016-receives-fda-emergency-use-authorization-for-covid-19-301225460.html ↩

  3. "New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent" (Press release). Eli Lilly and Company. 26 January 2021. Retrieved 9 February 2021 – via PR Newswire. https://www.prnewswire.com/news-releases/new-data-show-treatment-with-lillys-neutralizing-antibodies-bamlanivimab-ly-cov555-and-etesevimab-ly-cov016-together-reduced-risk-of-covid-19-hospitalizations-and-death--by-70-percent-301214598.html ↩

  4. Hurt AC, Wheatley AK (April 2021). "Neutralizing Antibody Therapeutics for COVID-19". Viruses. 13 (4): 628. doi:10.3390/v13040628. PMC 8067572. PMID 33916927. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067572 ↩

  5. "etesevimab". IUPHAR/BPS Guide to Pharmacology. Retrieved 10 February 2021. https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=11331 ↩

  6. "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). 28 October 2020. https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-us-government-supply-300000-vials ↩

  7. "FDA authorizes bamlanivimab and etesevimab for COVID-19". U.S. Food and Drug Administration (FDA). 16 September 2021. Archived from the original on 17 September 2021. Retrieved 16 September 2021. https://web.archive.org/web/20210917083810/https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-bamlanivimab-and-etesevimab-monoclonal-antibody-therapy-post-exposure-prophylaxis ↩

  8. "Emergency Use Authorization 094". U.S. Food and Drug Administration (FDA). 16 September 2021. Archived from the original (PDF) on 10 February 2021. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210011139/https://www.fda.gov/media/145801/download ↩

  9. "FDA authorizes bamlanivimab and etesevimab for COVID-19". U.S. Food and Drug Administration (FDA). 16 September 2021. Archived from the original on 17 September 2021. Retrieved 16 September 2021. https://web.archive.org/web/20210917083810/https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-bamlanivimab-and-etesevimab-monoclonal-antibody-therapy-post-exposure-prophylaxis ↩

  10. "Emergency Use Authorization 094". U.S. Food and Drug Administration (FDA). 16 September 2021. Archived from the original (PDF) on 10 February 2021. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210011139/https://www.fda.gov/media/145801/download ↩

  11. "Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant" (Press release). U.S. Food and Drug Administration (FDA). 24 January 2022. Archived from the original on 24 January 2022. Retrieved 24 January 2022. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20220124215636/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron ↩

  12. "Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant" (Press release). U.S. Food and Drug Administration (FDA). 24 January 2022. Archived from the original on 24 January 2022. Retrieved 24 January 2022. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20220124215636/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron ↩

  13. "Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19" (Press release). Eli Lilly and Company. 9 February 2021. Retrieved 9 February 2021 – via PR Newswire. https://www.prnewswire.com/news-releases/lillys-bamlanivimab-ly-cov555-administered-with-etesevimab-ly-cov016-receives-fda-emergency-use-authorization-for-covid-19-301225460.html ↩

  14. "etesevimab". IUPHAR/BPS Guide to Pharmacology. Retrieved 10 February 2021. https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=11331 ↩

  15. "Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19" (Press release). Eli Lilly and Company. 9 February 2021. Retrieved 9 February 2021 – via PR Newswire. https://www.prnewswire.com/news-releases/lillys-bamlanivimab-ly-cov555-administered-with-etesevimab-ly-cov016-receives-fda-emergency-use-authorization-for-covid-19-301225460.html ↩

  16. "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). 28 October 2020. https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-us-government-supply-300000-vials ↩

  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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  18. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  19. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  20. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  21. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  22. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  23. "The Biden administration buys 100,000 doses of a combination antibody treatment for high-risk Covid-19 patients". The New York Times. 26 February 2021. Archived from the original on 20 September 2021. Retrieved 30 September 2021. https://web.archive.org/web/20210920104845/https://www.nytimes.com/2021/02/26/world/bamlanivimab-etesevimab-eli-lilly-monoclonal-antibodies.html ↩

  24. "FDA authorizes bamlanivimab and etesevimab for COVID-19". U.S. Food and Drug Administration (FDA). 16 September 2021. Archived from the original on 17 September 2021. Retrieved 16 September 2021. https://web.archive.org/web/20210917083810/https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-bamlanivimab-and-etesevimab-monoclonal-antibody-therapy-post-exposure-prophylaxis ↩

  25. "Emergency Use Authorization 094". U.S. Food and Drug Administration (FDA). 16 September 2021. Archived from the original (PDF) on 10 February 2021. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210011139/https://www.fda.gov/media/145801/download ↩

  26. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  27. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210416204530/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab ↩

  28. "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. This article incorporates text from this source, which is in the public domain. https://web.archive.org/web/20210210004700/http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0 ↩

  29. "EMA reviewing data on monoclonal antibody use for COVID-19" (Press release). European Medicines Agency (EMA). 4 February 2021. Retrieved 4 March 2021. https://www.ema.europa.eu/en/news/ema-reviewing-data-monoclonal-antibody-use-covid-19 ↩

  30. "EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)" (Press release). European Medicines Agency (EMA). 5 March 2021. Retrieved 5 March 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. https://www.ema.europa.eu/en/news/ema-issues-advice-use-antibody-combination-bamlanivimab-etesevimab ↩

  31. "EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)" (Press release). European Medicines Agency (EMA). 5 March 2021. Retrieved 5 March 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. https://www.ema.europa.eu/en/news/ema-issues-advice-use-antibody-combination-bamlanivimab-etesevimab ↩

  32. "Bamlanivimab and etesevimab for COVID-19: Withdrawn application". European Medicines Agency. 2 November 2021. Retrieved 4 November 2021. https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/bamlanivimab-etesevimab-covid-19 ↩

  33. "EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly". European Medicines Agency (EMA) (Press release). 2 November 2021. Retrieved 4 November 2021. https://www.ema.europa.eu/en/news/ema-ends-rolling-review-antibodies-bamlanivimab-etesevimab-covid-19-following-withdrawal-lilly ↩