FDA backs emergency use of bebtelovimab for COVID-19

The US Food and Drug Administration has issued an Emergency Use Authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the Omicron variant.

The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, 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 the FDA are not accessible or clinically appropriate.

Bebtelovimab (LY-CoV1404) is the second antibody developed through Canada-based AbCellera’s (Nasdaq: ABCL) collaboration with US pharma major Eli Lilly (NYSE: LLY).