The United States Food and Medication Administration approved Eli Lilly and Co’s (LLY.N) COVID-19 antibody drug for persons aged 12 and up who are at risk of severe disease on Friday, adding a tool that has been proven to work against the highly infectious Omicron strain.
The FDA has approved bebtelovimab for emergency use in individuals with mild-to-moderate COVID-19 who are at high risk of developing severe illness, which might result in hospitalisation or death.
Bebtelovimab should be used when alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate, the agency said.
The U.S. health regulator had in January revised the emergency use authorizations for Lilly’s antibody combination treatment and a rival therapy from Regeneron (REGN.O) after the drugs were found to be ineffective against the Omicron variant.
Lilly has said bebtelovimab retains activity against Omicron as well as its BA. 2 subvariant, which is said to be more transmissible.
The company on Thursday signed a supply deal with the U.S. government for up to 600,000 doses of bebtelovimab to be delivered by the end of March.
Bebtelovimab was originally discovered by AbCellera Biologics (ABCL.O) and later licensed and developed by Eli Lilly.