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 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 (Code C182122)". National Cancer Institute. Archived from the original on 13 February 2022. Retrieved 12 February 2022. This article incorporates text from this source, which is in the public domain.
"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
This article incorporates text from this source, which is in the public domain.
Viruses
COVID-19
