FDA suspends authorization of Evusheld, citing insufficient drugs against viral variants of COVID-19

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The U.S. Food and Drug Administration on Thursday suspended Evusheld’s emergency use authorization because it does not appear to protect against COVID-19 virus variants currently circulating in the United States.

The video in the media player is from a previous report.

Evusheld is a monoclonal antibody therapy used to prevent COVID-19 in immunocompromised people, who are less likely to generate an immune response following vaccination against COVID-19.

US officials have warned for months that antibody therapy doesn’t work against some emerging variants, but it’s still available. CNN previously reported that many patients who used the drug were unaware that the drug was no longer as effective as it once was and continued to rely on it to protect against COVID-19.

On Thursday, the FDA revised Evusheld’s emergency use authorization to limit it to when the combined frequency of non-susceptible coronavirus variants is 90% or less.

The data showed that Evusheld is unlikely to perform against XBB, XBB.1.5, BQ.1, and BQ.1.1; combined, these variants are estimated to cause nearly 93% of new COVID-19 cases in the United States.

“This means that Evusheld is not expected to provide protection against the development of COVID-19 if exposed to these variants,” the FDA said in a statement Thursday.

The agency said if someone is infected and develops symptoms of COVID-19, they should see a doctor and may be able to use antivirals Paxlovid, remdesivir or molnupiravir, all of which work against the variants currently in circulation. .

Several antibody therapies used against COVID-19 earlier in the pandemic are no longer available because the virus has evolved and they are no longer effective. AstraZeneca, the maker of Evusheld, said in a statement it was studying the safety and efficacy of a “next-generation long-acting antibody” to prevent COVID-19 in immunocompromised people.

Although Evusheld is currently unlicensed, the FDA has said suppliers should hold onto the drug.

“The U.S. government recommends that Evusheld facilities and suppliers retain all products in case the SARS-CoV-2 variants neutralized by Evusheld become more prevalent in the United States in the future,” the agency said. .

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