FDA Reauthorizes Eli Lilly COVID-19 Antibody Cocktail, But Not Everywhere

September 1, 2021

The FDA has reissued its Emergency Use Authorization (EUA) for Eli Lilly’s monoclonal antibodies bamlanivimab and etesevimab for treatment of mild-to-moderate COVID-19 infections — but only for certain states.

FDA Chief Scientist Denise Hinton said the antibodies can only be used in those states, territories or other U.S. jurisdictions “in which the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5 percent.” As of Aug. 27, only 22 states fit into that category.

The EUA was originally granted in February but its distribution was restricted in late March due to concerns about an increase in variants of SARS-CoV-2 that are resistant to the drug.

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