The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and Company (NYSE: LLY) announced today.
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, including 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.
"As a global pharmaceutical company, Lilly has worked hard to fight this pandemic. Early in 2021, prior to the identification of the Omicron variant, Lilly scientists were already working to develop bebtelovimab as a broadly neutralizing antibody that could be used to fight a highly mutated variant, should one emerge," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories. "With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic."
The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. This trial was a Phase 2, randomized, clinical trial evaluating treatment of non-hospitalized 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
