FDA revises EUAs for two monoclonal antibody treatments, Florida disputes move

On Monday, the U.S. Food and Drug Administration (FDA) reissued the emergency use authorizations (EUAs) for Eli Lilly’s bamlanivimab-etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab) monoclonal antibody treatments, which states these treatments are not authorized for use in any U.S. state, territory, or jurisdiction at this time.

FDA states:

Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.  

Based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time. This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.  

The Florida Department of Health responded to the FDA move:

Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the FDA.

As stated in one of the pre-print studies cited at the NIH website, “despite observing differences in neutralizing activity with certain mABs, it remains to be determined how this finding translates into effects on clinical protection against B.1.1.529.”

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