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FDA Authorizes Lilly COVID-19 Antibody Combination for Emergency Use

The FDA last night granted Emergency Use Authorization (EUA) for a 700 mg dose of bamlanivimab (LY-CoV555) in combination with a 1400 mg dose of a second Lilly antibody candidate, etesevimab (LY-CoV016), for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

The EUA is the second for bamlanivimab, and comes three months after the agency authorized emergency use of the antibody by itself, administered via a single intravenous infusion at the lowest IV dose studied in clinical trials.

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