Bebtelovimab

Bebtelovimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetSpike protein of SARS-CoV-2
Clinical data
Pronunciation/ˌbɛbtɪˈloʊvɪmæb/
BEB-tih-LOHV-ih-mab[1]
Other namesLY-CoV1404, LY3853113
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
  • US: Withdrawn
Identifiers
KEGG

Bebtelovimab is a monoclonal antibody developed by AbCellera and Eli Lilly as a treatment for COVID-19.[2][3][4][5]

Possible side effects include itching, rash, infusion-related reactions, nausea and vomiting.[2]

Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death.[2] Bebtelovimab is a neutralizing human immunoglobulin G1 (IgG1) monoclonal antibody, isolated from a patient who has recovered from the Coronavirus disease 2019 (COVID-19), directed against the spike (S) protein of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), that can potentially be used for immunization against COVID-19.[6]

As of November 2022, bebtelovimab is not authorized for emergency use in the US because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.[7]

Medical uses

Bebtelovimab was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in February 2022,[2] and revoked it in November 2022.[7] The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in people aged 12 years of age and older weighing at least 40 kilograms (88 lb) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.[2]

Bebtelovimab is not authorized for people who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.[2] Treatment with bebtelovimab has not been studied in people hospitalized due to COVID-19.[2]

Bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.[8]

History

Bebtelovimab emerged from a collaboration between Eli Lilly and AbCellera.[3] Bebtelovimab was discovered by AbCellera and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.[3][4]

Society and culture

Bebtelovimab was authorized for medical use in the United States via an emergency use authorization in February 2022.[2][9][10][11]

As of November 2022, bebtelovimab is not authorized for emergency use in the US because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.[7][10] Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice by the U.S. Food and Drug Administration (FDA).[7]

Names

Bebtelovimab is the proposed international nonproprietary name (pINN).[12]

References

  1. ^ "Emergency Use Authorization (EUA) for the Treatment of COVID-19". Lilly. Archived from the original on 28 July 2022. Retrieved 28 July 2022.
  2. ^ a b c d e f g h "FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant" (Press release). U.S. Food and Drug Administration (FDA). 11 February 2022. Archived from the original on 12 February 2022. Retrieved 12 February 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ a b c "Lilly's bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19" (Press release). Eli Lilly and Company. 11 February 2022. Archived from the original on 11 February 2022. Retrieved 12 February 2022 – via PR Newswire.
  4. ^ a b "AbCellera-Discovered Antibody, Bebtelovimab, Receives U.S. FDA Emergency Use Authorization for the Treatment of Mild-to-Moderate COVID-19" (Press release). AbCellera. 11 February 2022. Archived from the original on 11 February 2022. Retrieved 12 February 2022.
  5. ^ Suran M (March 2022). "Federal Government Buys Thousands of Bebtelovimab Doses". JAMA. 327 (12): 1117. doi:10.1001/jama.2022.3520. PMID 35315904. S2CID 247599102.
  6. ^ "Bebtelovimab (Code C182122)". National Cancer Institute. Archived from the original on 13 February 2022. Retrieved 12 February 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ a b c d "FDA Announces Bebtelovimab is Not Currently Authorized in the US". U.S. Food and Drug Administration. 30 November 2022. Retrieved 1 December 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ "FDA Updates on Bebtelovimab". U.S. Food and Drug Administration (FDA). 4 November 2022. Retrieved 12 November 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ "Emergency Use Authorization (EUA) Of Bebtelovimab" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on 12 February 2022. Retrieved 12 February 2022.
  10. ^ a b "Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bebtelovimab" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on 11 February 2022. Retrieved 12 February 2022.
  11. ^ "Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab for the Treatment of COVID-19" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on 12 February 2022. Retrieved 12 February 2022.
  12. ^ World Health Organization (2021). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 126 – COVID-19 (special edition)". WHO Drug Information. 35 (4): 1130–1. Archived from the original on 13 February 2022. Retrieved 13 February 2022.
  • "Bebtelovimab". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT04634409 for "A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)" at ClinicalTrials.gov
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