The Food and Drug Administration on Monday amended the authorizations of two monoclonal antibody COVID-19 treatments that likely do not work on the omicron variant.
The agency now only recommends the use of the therapies made by Eli Lilly and Regeneron “when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.”
Given that the omicron variant makes up virtually all of the infections in the U.S., the change effectively ends the current authorized use of the drugs.
Cartoons on the Coronavirus
“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,” Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
However, in the future, the drugs could be used “if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments,” Cavazzoni said.
The move comes after a National Institutes for Health committee last week recommended against the use of the Regeneron and Lilly antibody drugs, saying they “are predicted to have markedly reduced activities” against omicron.
The FDA noted that several other therapies – including Paxlovid, remdesivir, and molnupiravir – are expected to work against the omicron variant.