WASHINGTON — The Food and Drug Administration revoked emergency authorization for the antibody drugs used in the treatments, saying they don’t work against the omicron variant.
The drugs, made by Regeneron and Eli Lilly, have been administered to millions of Americans with COVID-19, and the FDA said in a statement if the drugs are effective against future variants their use could be reauthorized, The Associated Press reported.
The Florida Department of Health, in a tweet, announced that the FDA’s decision meant that all monoclonal antibody treatment sites would immediately be closed. On Tuesday, more than 2,000 Floridians were scheduled for treatment that was canceled, WFTV reported.
As a result of the @US_FDA's abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below. pic.twitter.com/RGeWTPwxCs
— Florida Dept. of Health (@HealthyFla) January 25, 2022
In a news release, the Florida’s Department of Health said, “Florida disagrees with the decision that blocks any access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the FDA.”
In its statement announcing the decision, the FDA said that Centers for Disease Control and Prevention data show the omicron variant accounts for more than 99% of cases in the United States as of Jan. 15. Because most patients are infected with omicron, the FDA said eliminating the monoclonal antibody treatments “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.”
In a statement, Florida Gov. Ron DeSantis demanded the Biden administration reverse “its sudden and reckless decision,” WFTV reported. “Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law.”
Both Regeneron and Eli Lilly have previously announced they are working to develop new antibodies that target omicron, The Associated Press reported.
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