FDA Revokes Lilly’s bamlanivimab EUA As Its Efficacy Wanes Against SARS-CoV-2 Variants

FDA Revokes Lilly’s bamlanivimab EUA As Its Efficacy Wanes Against SARS-CoV-2 Variants

The U.S. Food and Drug Administration (FDA) just recently revoked the emergency use authorization (EUA) for bamlanivimab, the investigational monoclonal therapy, when administered alone for the use of treatment for mild-to-moderate COVID-19 in adults and certain pediatric patients. The FDA has determined that the known and potential benefits of the investigational monoclonal antibody when administered alone no longer outweigh the known and possible risks for its authorized use. Why? Because of an ongoing analysis by the FDA, when combined with emerging data, indicate that sustained increase of SARS-CoV-2 viral variants that are resistant to the monoclonal antibody product produced by Eli Lilly and Co. (Lilly) result in increased risk for treatment failure. Consequently, the FDA has revoked the EUA. Bamlanivimab also faltered in the NIH-sponsored ACTIV- 3 trial centering on hospitalized patients last October. The monoclonal antibody can still be used with Lilly’s etesevimab, licensed by a Chinese biotech, based on data generated from the BLAZE-1 clinical trial. Also still available is the monoclonal antibody cocktail produced by Regeneron known as REGEN-COV (Casirivimab and imdevim...

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