Bebtelovimab is expected to have reduced activity against certain emerging Omicron subvariants of SARS-CoV-2, according to an updated alert from the Food and Drug Administration (FDA).
Bebtelovimab is a recombinant neutralizing human IgG1κ monoclonal antibody that works by binding to the spike protein of SARS-CoV-2. The product is currently authorized for emergency use for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40kg):
- with positive results of direct SARS-CoV-2 viral testing, 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 FDA are not accessible or clinically appropriate.
The FDA has updated the Fact Sheets for Health Care Providers for bebtelovimab with information regarding the expected activity against the SARS-CoV-2 Omicron variants in the US, particularly Omicron subvariants BQ.1 and BQ.1.1. According to recent data, bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.
Bebtelovimab will remain authorized in all US regions until further notice. Health care providers are advised to monitor CDC regional variant frequency data to identify and track the activity of SARS-CoV-2 variants.
In a statement, the FDA noted that alternative therapies such as Paxlovid, Veklury (remdesivir), and Lagevrio (molnupiravir) are expected to work against the BQ.1 and BQ.1.1 subvariants. These treatments are authorized or approved to treat patients with mild to moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.
FDA updates on bebtelovimab. News release. US Food and Drug Administration. Accessed November 4, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab
This article originally appeared on MPR