FDA lays aside Lilly's bebtelovimab in the U.S. for emergency use treatment of mild-to-moderate COVID-19 in adults and pediatric patients. Over the last several months, prevalence of COVID variant sublineages vary by state, region and even country, and can change rapidly.
Lilly said that it agrees with the FDA that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US.
Based on pseudovirus data, Lilly can confirm that bebtelovimab does not retain neutralization activity against the BQ.1 and BQ.1.1 variants, most likely due to an amino acid K444T substitution.
Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients.
Lilly will pause all distribution of bebtelovimab. Any unused bebtelovimab may be kept during the pause—please follow storage and handling as specified in the Fact Sheet.
Lilly continually monitors the global COVID-19 environment, assessing the neutralization activity of potential antibody therapies against a wide array of existing and emerging mutations and variants. It will continue to search and evaluate monoclonal antibodies to identify potential candidates for clinical development against new variants.
