US FDA Withdraws Authorization of AstraZeneca’s Evusheld

HEALTHCARE

Because it is not anticipated that AstraZeneca’s COVID-19 antibody cocktail Evusheld will neutralize the Omicron subvariant’s XBB.1.5 subvariant, the U.S. health regulator has revoked the treatment’s emergency-use authorization.

Evusheld’s use had been restricted earlier this month for the same reason by the Food and Drug Administration (FDA), and the agency’s announcement on Thursday sent U.S. shares of London-based AstraZeneca down 1.31 percent to $65.75.

Since December 2022, Omicron subvariant XBB.1.5 has spread rapidly throughout the nation, accounting for nearly half of all COVID-19 cases in the United States last week, according to government data. The decision made by the FDA is in line with the European health regulator’s concerns regarding the effectiveness of monoclonal antibodies like Evusheld against more recent variants.

According to AstraZeneca, the FDA has informed the company that it will consider reauthorizing Evusheld if the prevalence of resistant variants in the United States decreases to 90 percent or less consistently. Regarding Evusheld and COVID-19 variants, the pharmaceutical company intends to continue sharing pertinent data with the FDA and other health authorities.

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Monoclonal antibodies work against the COVID-19 virus by binding to the spike protein on its surface. However, the virus has been evolving, which has altered this protein and affected how the antibodies work against it. Bebtelovimab, a COVID-19 medication manufactured by Eli Lilly and Co., also had its emergency use authorization revoked by the U.S. health regulator in November due to similar concerns.