Bebtelovimab is a

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ...

developed by

AbCellera AbCellera Biologics Inc. is a Vancouver, British Columbia-based biotechnology firm that researches and develops human antibodies. The company is best known for its leading role in the Pandemic Prevention Platform, a project of DARPA's Biologic ...

and

Eli Lilly Eli Lilly (July 8, 1838 – June 6, 1898) was an American soldier, pharmacist, chemist, and businessman who founded the Eli Lilly and Company pharmaceutical corporation. Lilly enlisted in the Union Army during the American Civil War and r ...

as a treatment for

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickl ...

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

Medical uses

Bebtelovimab was granted an

emergency use authorization An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, includ ...

(EUA) by the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) in February 2022, and revoked it in November 2022. 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 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. Bebtelovimab is not authorized for people who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Treatment with bebtelovimab has not been studied in people hospitalized due to COVID-19. Bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.

History

Bebtelovimab emerged from a collaboration between Eli Lilly and

. Bebtelovimab was discovered by AbCellera and the

National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's ...

(NIAID)

Vaccine Research Center The Vaccine Research Center (VRC), is an intramural division of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), US Department of Health and Human Services (HHS). The mission of ...

Society and culture

Legal status

Bebtelovimab was authorized for medical use in the United States via an emergency use authorization in February 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. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice by the U.S.

(FDA).

Names

Bebtelovimab is the proposed international nonproprietary name (pINN).

References

External links

* * Antiviral drugs Experimental drugs COVID-19 drug development Monoclonal antibodies {{antiinfective-drug-stub