Bebtelovimab is currently not authorized for emergency use to treat COVID-19 in any US state or territory at this time, according to an updated alert from the Food and Drug Administration (FDA). 

The latest data from the Centers for Disease Control and Prevention show that the SARS-CoV-2 variants BQ.1 and BQ.1.1 account for more than 57% of COVID-19 cases nationally, and continue to be increasingly prevalent across all US regions. Neutralization data indicate that bebtelovimab is not expected to neutralize these variants and as such is no longer authorized for use at this time. The updated information can be found in the Fact Sheet for Health Care Providers.

Health care providers are urged to consider alternative therapies such as PaxlovidVeklury (remdesivir), and Lagevrio (molnupiravir), which 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.

The commercial distribution of bebtelovimab has been paused by Eli Lilly and its authorized distributors until further notice. Product that has already been distributed should be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab become more prevalent in the future in the US.

Reference

FDA announces bebtelovimab is not currently authorized in any US region. News release. US Food and Drug Administration. Accessed November 30, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-bebtelovimab-not-currently-authorized-any-us-region