February 15, 2022 -- The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Eli Lilly's antibody bebtelovimab, which demonstrates neutralization against the omicron COVID-19 variant.
Bebtelovimab can now be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19. This includes those at risk of hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
The data supporting this EUA are primarily based on analyses from the phase II BLAZE-4 trial (NCT04634409), treatment arms 9-14. This trial was a phase II, randomized, clinical trial evaluating treatment of nonhospitalized patients with mild-to-moderate COVID-19 who were treated with the authorized dose of bebtelovimab (175 mg) alone or together with 700 mg bamlanivimab and 1,400 mg of etesevimab.
Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against omicron, which is currently the predominant variant in the U.S. In addition, pseudovirus testing with bebtelovimab demonstrates that it retains neutralization against all other known variants of interest and concern, including the BA.2 variant of COVID-19.
Eli Lilly has signed an agreement with the U.S. government to supply up to 600,000 doses of bebtelovimab for at least $720 million.