Lilly Antibody Bebtelovimab Gets FDA EUA for Certain Mild-to-Moderate Covid-19 Patients

By Josh Beckerman

Eli Lilly & Co.'s bebtelovimab, a monoclonal antibody discovered by AbCellera Biologics Inc., received Emergency Use Authorization from the U.S. Food and Drug Administration for certain Covid-19 patients.

The EUA is for mild-to-moderate Covid-19 in adults and children 12-and-up weighing at least 88 pounds with a positive COVID-19 test, and who are at high risk for progression to severe Covid-19, and for whom alternative treatment options approved or authorized by the FDA aren't accessible or clinically appropriate, the FDA said.

The agency "is carefully monitoring circulating viral variants and their sensitivity to authorized monoclonal antibodies, including bebtelovimab."

Lilly said the authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.

Last month, the FDA restricted Lilly's bamlanivimab and etesevimab combination, as well as Regeneron Pharmaceuticals Inc.'s REGEN-COV, citing lack of effectiveness against the omicron variant. AbCellera discovered bamlanivimab.

Lilly said Thursday that it agreed to supply 600,000 doses of bebtelovimab for at least $720 million in an agreement with the U.S. government, subject to receiving the EUA.

"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," the company said Friday.

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

February 11, 2022 16:44 ET (21:44 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.