The U.S. Food and Drug Administration (FDA) issued an order to limit the use of two monoclonal antibody drugs deemed to be ineffective against the Omicron variant of COVID-19.
FDA regulators said they revised the authorization for use of monoclonal antibody drugs from Regeneron and Eli Lilly—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab)—restricting their use to patients deemed likely to have been infected with a COVID-19 variant that is susceptible to these treatments. The decision triggered criticism from Florida Gov. Ron DeSantis, according to reports.
“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,” the FDA said in a statement.
Based on Centers for Disease Control (CDC) data, the Omicron variant is estimated to account for more than 99% of cases in the United States as of Jan. 15, health regulators noted.
According to the Associated Press, the FDA move was expected because both drugmakers had said the infusion drugs are less able to target Omicron due to its mutations.
Florida governor opposes decision
Florida Gov. DeSantis expressed his opposition to the FDA decision, accusing the officials of “messing with our monoclonal antibodies for months and months,” CBS reported.
“People have a right to access these treatments, and to revoke it on this basis is just fundamentally wrong and we’re going to fight back,” DeSantis said at a news conference, ABC News reported.
Florida’s Department of Health issued a statement saying that while it disagrees with the FDA’s decision, it is closing all of its monoclonal antibody treatment sites until further notice.
DeSantis has heavily promoted antibody drugs as a signature part of his administration’s COVID-19 response, while opposing vaccine mandates and other public health measures, CBS adds.
The FDA also noted that it continues to review emerging data on all therapies related to the potential impact of the COVID-19 variants.