FDA grants emergency use of antibody effective against omicron

The FDA on Feb. 11 issued an emergency use authorization for Eli Lilly's bebtelovimab, a monoclonal antibody treatment that works against omicron. 

Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 among those 12 and older who weigh at least 88 pounds and who are at high risk of developing severe illness. It's intended for use when "alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate." 

Data from Eli Lilly lab tests have shown the drug is effective against omicron and the BA.2 subvariant. 

The federal government had already purchased 600,000 courses of the treatment in a $720 million deal with Eli Lilly, Bloomberg reported Feb. 10. 

"Should the BA.2 subvariant grow in proportion in the U.S., this potential treatment may help ensure that we can continue to offer a monoclonal antibody treatment that works against that strain of the virus," HHS said in a Feb. 10 news release, adding the drug would be provided to states for free. 

Under the purchase agreement, HHS will receive 300,000 treatment courses in February and the second half in March. The contract also includes an option to purchase an additional 500,000 doses in the future. 

In January, the FDA removed Eli Lilly's antibody therapy — balansavimas administered with eteseviman — and another made by Regeneron due to their ineffectiveness against omicron. 


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