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For: EFE
The Food and Drug Administration withdrew from the market
The FDA reported that it withdrew its authorization for the use of Bamlanivimab and Etesevimab, from the pharmaceutical company Eli Lilly- and from REGEN-COV, made up of Casirivimab and Imdevimab, from Regeneron.
“The data show that these treatments are highly unlikely to be active against the omicron variant, which is expanding rapidly in the United States,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. .
As of now, these drugs “are no longer authorized for use in any US state, territory or jurisdiction”.
“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, their use in those regions could be authorized,” added Cavazzoni.
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).
The elimination of treatments “avoids exposing patients to side effects, such as reactions at the injection site or allergic reactions that can be potentially serious” in patients infected with omicron, explained the doctor.
The FDA recalled that there are several authorized treatments in the country that are expected to work against the omicron variant in the case of patients who are at risk of developing severe disease, citing among them Paxlovid, Sotrovimab, V eklury (Remdesivir) and Molnupiravir.
The agency followed the recommendation of a committee of the National Institutes of Health (NIH), which last week advised against the use of Eli Lilly therapies and Regeneron considering that they had a “significantly reduced” effect against omicron.
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