FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

FDA announced on Nov. 30, 2022 that bebtelovimab is not currently authorized for emergency use in any region of the United States because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1, according to data included in the Health Care Provider Fact Sheet.

Commercial distribution of bebtelovimab has been halted by Eli Lilly and its authorized distributers until further notice by FDA. The Administration for Strategic Preparedness and Response (ASPR) has also paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative.

The US government has recommended all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab become more prevalent in the future in the US. These variants are currently circulating at lower prevalence.