The United States Food and Drug Administration (FDA) withdrew two monoclonal antibody therapies from the list of approved treatments against covid-19 in the country on Monday, assuring that they are not effective against the omicron variant.
The FDA reported in a statement that it has withdrawn its authorization for the use of the therapies bamlanivimab and etesevimab -which are administered together, from the pharmaceutical company Eli Lilly- and REGEN-COV, made up of basiliximab and imdevimab, from Regeneron.
“The data show that it is very unlikely that these treatments will activate against the omicron variant, which is circulating at a very high frequency in the United States,” said the director of the FDA’s Center for Drug Evaluation and Research, in the note. Patrizia Cavazzoni.
Thus, as of now, those drugs “are no longer authorized for use in any US state, territory, or jurisdiction.”, he continued.
“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 these treatments could be licensed for use in those regions,” Cavazzoni added.
The omicron variant accounts for more than 99% of covid-19 cases in the United States, according to data from the Centers for Disease Control and Prevention (CDC).
Removing authorization for these therapies for now “avoids exposing patients to side effects, such as injection site reactions or allergic reactions that can be potentially serious, from treatments that are not expected to be of benefit” to patients. patients infected with ómicron explained the doctor.
The FDA recalled that there are several therapies authorized in the United States that are expected to work against the omicron variant in patients who are at risk of developing severe disease, citing Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir among them.
The agency followed the recommendation of a committee of the National Institutes of Health (NIH, in English), which last week advised against the use of Eli Lilly and Regeneron therapies, considering that they had a “markedly reduced” effect against omicron.
Florida Governor Ron DeSantis, a Republican, last week ignored those NIH findings and said he wanted to continue administering such treatments in his state, something he will now be unable to do.
In a statement, DeSantis condemned the FDA’s decision and said that it has caused the cancellation of more than 2,000 appointments to receive this treatment only this Tuesday, the 25th.