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January 31, 2022- FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

Monday, January 31, 2022

The U.S. Food and Drug Administration (FDA) has issued updated Emergency Use Authorization (EUA) fact sheets for two COVID-19 monoclonal antibody treatments: bamlanivimab and etesevimab (when administered together) and REGEN-COV (casirivimab and imdevimab administered together). After reviewing the current data, the FDA has made the decision to restrict the use of bamlanivimab/etesevimab and REGEN-COV to treat COVID-19 positive patients at this time. Data indicates that these two treatments are highly unlikely to be active against the Omicron variant which is circulating at a very high frequency throughout the United States.