Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Human |
Target | Spike protein of SARS-CoV-2 |
Clinical data | |
Pronunciation |
/ˌbɛbtɪˈloʊvɪmæb/ BEB-tih-LOHV-ih-mab [1] |
Other names | LY-CoV1404, LY3853113 |
License data |
|
Routes of administration | Intravenous |
ATC code |
|
Legal status | |
Legal status |
|
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 [update], 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]
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]
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]
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 [update], 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]
Bebtelovimab is the proposed international nonproprietary name (pINN). [12]
Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Human |
Target | Spike protein of SARS-CoV-2 |
Clinical data | |
Pronunciation |
/ˌbɛbtɪˈloʊvɪmæb/ BEB-tih-LOHV-ih-mab [1] |
Other names | LY-CoV1404, LY3853113 |
License data |
|
Routes of administration | Intravenous |
ATC code |
|
Legal status | |
Legal status |
|
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 [update], 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]
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]
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]
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 [update], 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]
Bebtelovimab is the proposed international nonproprietary name (pINN). [12]