Bamlanivimab/etesevimab

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Bamlanivimab/etesevimab
Combination of
BamlanivimabMonoclonal antibody
EtesevimabMonoclonal antibody
Clinical data
Main usesTreat or prevent COVID-19[1]
Side effectsPain at the site of injection, allergic reactions[2]
Routes of
use
Intravenous
External links
US NLMBamlanivimab/etesevimab
Legal
License data
Legal status

Bamlanivimab/etesevimab is a combination of medications used to treat or prevent COVID-19.[1] They are used in those who do not currently require hospitalization but are at high risk of getting worse.[1] It is much less effective for the Omicron variant.[6] It is given by injection into a vein.[1]

Side effects may include pain at the site of injection and allergic reactions including anaphylaxis.[2][7] While there is no evidence of safety in pregnancy, such use may still be recommended.[7] It is a combination of bamlanivimab and etesevimab, two monoclonal antibodies that bind to different parts of the surface spike protein of SARS‑CoV‑2.[1]

The combination has emergency use authorization in the United States.[1] Request for approval has been withdrawn in Europe.[8] As of January 2022 they continued to be distributed to part of the United States with low rates of resistance.[1] The combination costs the United States government about 2,100 USD per dose as of 2021.[9]

Medical use

Resistance has become common as of August 2021 in many parts of the United States.[10] It is much less effective for the Omicron variant.[6] It may be used in any age group.[1]

COVID-19

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.[3] Of these participants, 518 received a single infusion of bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams together, and 517 received placebo.[3] The primary endpoint was COVID-19 related hospitalizations or death by any cause during 29 days of follow-up.[3] 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.[3] All ten deaths (2%) occurred in the placebo group.[3] Thus, all-cause death was significantly lower in the bamlanivimab 2,800-milligram and etesevimab 2,800-milligram group than the placebo group.[3]

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.[4][5][5] 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.[3] 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] The EUA was issued to Eli Lilly and Co.[3]

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.[12] 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.[13] 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.[13] In October 2021, the CHMP ended the rolling review of bamlanivimab/etesevimab.[14][15]

Dosage

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

Contents

Etesevimab

Etesevimab is a monoclonal antibody against the surface spike protein of SARS‑CoV‑2.[16][17]

Eli Lilly licensed etesevimab from Junshi Biosciences.[16]

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.[18]

Economics

On 26 February 2021, the United States government agreed to purchase 100,000 doses of the drug for $210 million, at $2,100 per dose.[19]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 "Anti-SARS-CoV-2 Monoclonal Antibodies". COVID-19 Treatment Guidelines. Retrieved 8 January 2022.
  2. 2.0 2.1 "Fact Sheet for Patients, Parents and Caregivers Emergency Use Authorization (EUA) of Bamlanivimab and Etesevimab for Coronavirus Disease 2019 (COVID-19)". FDA. Retrieved 8 January 2022.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 "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.
  4. 4.0 4.1 "FDA authorizes bamlanivimab and etesevimab for COVID-19". U.S. Food and Drug Administration. 16 September 2021. Retrieved 16 September 2021.
  5. 5.0 5.1 5.2 "Emergency Use Authorization 094" (PDF). U.S. Food and Drug Administration (FDA). 16 September 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  6. 6.0 6.1 "Statement on Therapies for High-Risk, Nonhospitalized Patients". COVID-19 Treatment Guidelines. Retrieved 6 January 2022.
  7. 7.0 7.1 "Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) of Bamlanivimab and Etesevimab". FDA. Retrieved 8 January 2022.
  8. "Bamlanivimab". SPS - Specialist Pharmacy Service. 11 February 2021. Retrieved 8 January 2022.
  9. "US to buy more doses of Lilly's Covid-19 antibody therapy". Pharmaceutical Technology. 1 March 2021. Retrieved 8 January 2022.
  10. "Monoclonal Antibody Therapeutic Updates". www.phe.gov. Retrieved 8 November 2021.
  11. "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. Public Domain This article incorporates text from this source, which is in the public domain.
  12. "EMA reviewing data on monoclonal antibody use for COVID-19" (Press release). European Medicines Agency (EMA). 4 February 2021. Retrieved 4 March 2021.
  13. 13.0 13.1 "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 © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. "Bamlanivimab and etesevimab for COVID-19: Withdrawn application". European Medicines Agency. 2 November 2021. Retrieved 4 November 2021.
  15. "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.
  16. 16.0 16.1 "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.
  17. "etesevimab". IUPHAR/BPS Guide to Pharmacology. Retrieved 10 February 2021.
  18. "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.
  19. "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.

 This article incorporates public domain material from the United States Department of Health and Human Services website https://www.fda.gov/.

External links

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