Meet the two treatments withdrawn from the market by the FDA for not working against omicron

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Eliminating treatments avoids exposing patients to side effects.

Photo: CHAIDEER MAHYUDDIN/Getty Images

The Food and Drug Administration withdrawn from the market two treatments on the list of approved drugs against covid-19 because they are not effective against the omicron variant.

The FDA reported that it withdrew its authorization for the use of Bamlivimab and Etesevimab, from the pharmaceutical company Eli Lilly- and 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, those 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 licensed,” 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).

Eliminating treatments “avoids exposing patients to side effects, such as injection site reactions or allergic reactions that can be potentially serious” in patients infected with omicron, explained the doctor.

The FDA recalled that there are several treatments authorized 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, Veklury (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 and Regeneron therapies, considering that they had a “remarkably reduced” effect against omicron.

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