Fact Check By: Craig Jones, Newswise



Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments.

Claim Publisher and Date: Ron DeSantis on 2022-01-25

Florida Governor Ron DeSantis, along with other Republicans, objected when the FDA announced it was no longer authorizing two COVID-19 monoclonal antibody drugs in the U.S., claiming the decision was made without supporting data. However, recent lab studies strongly suggest the treatments will not help omicron-infected people, as this correspondence in the New England Journal of Medicine explains.

The two drugs, made by Regeneron and by Eli Lilly, were known to be effective at treating the original strain of the coronavirus, as well as the Delta variant. However, studies in labs have shown they do not work against omicron. According to the Centers for Disease Control and Prevention (CDC), more than 99 percent of infections nationwide are now from omicron. The FDA's decision was also supported by both manufacturers, which said they are working on new treatments that work against all known variants.  According to the Food and Drug Administration, the two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) are now limited to only patients that have "likely been infected with or exposed to a variant that is susceptible to these treatments." 

As reported by Julia Marnin of the Sacramento Bee...

Regeneron’s monoclonal antibody treatment, REGEN-COV (casirivimab and imdevimab), and Eli Lilly’s monoclonal antibody treatment, bamlanivimab and etesevimab, are “highly unlikely to be active against the omicron variant” according to recent data, said Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, in a Jan. 24 news release.

Now, their use will be allowed only when a patient “is likely to have been infected with or exposed to a variant that is susceptible to these treatments,” Cavazzoni said. “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.” Cavazzoni said this will prevent patients from experiencing certain side effects from these drugs, including potential serious allergic reactions, “that are not expected” to help treat those who’ve been infected with omicron.