The US FDA stopped using two COVID-19 treatments for not being effective against the Omicron variant

United States FDA facade

The Food and Drug Administration (FDA) of The United States 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The FDA reported in a statement that it has withdrawn its authorization for the use of the therapies bamlanivimab and etesevimab -which are administered together, from the pharmaceutical company Eli Lilly- and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 casirivimab and imdevimab, from Regeneron.

“The data shows that these treatments are very unlikely to activate against the Omicron variant, which is circulating at a very high frequency in the United StatesPatrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in the note.

Therefore, as of now, those drugs “are no longer authorized for use in any state, territory or jurisdiction of the United States,” 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).

CDC facilities in the US
CDC facilities in the US

Removing the authorization of 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” for patients. patients infected with Omicron, 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 it has caused more than 2,000 appointments to receive this treatment to be canceled on Tuesday the 25th alone.

(With information from EFE)


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