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FDA Withdraws Authorization for COVID Drug Evusheld

covid 19 virus

Jan. 28, 2023 -- The U.S. Food and Drug Administration has withdrawn emergency use authorization for the COVID-19 antibody drug Evusheld because the drug is not effective against the Omicron variants now dominating the nation.

Evusheld was designed to prevent COVID infection in people with compromised immune systems. The FDA authorized the drug in December 2021, before Omicron variants like XBB and XBB.1.5 began circulating. 

Those and some other Omicron variants are now responsible for more than 90% of current COVID infections in the U.S., the FDA said in a news release

“Like other viruses, SARS-CoV-2 can mutate over time, resulting in certain products not working against certain variants,” the FDA said. “This is the case with Evusheld and prompted the changes to the authorization that FDA is making today.”

However, people and facilities with stocks of Evusheld should not throw the drug away in case those old variants become prevalent again, the news release advised. 

Evusheld was intended to help people who have received organ or other transplants, and those who have cancer or take immune-suppressing drugs for conditions such as rheumatoid arthritis.

AstraZeneca, the maker of Evusheld, said in a statement that it’s working on a “next-generation long-acting antibody” to prevent Covid-19 among immune-compromised people.

Other antibody therapies such as bebtelovimab have also lost authorization because they don’t work against the currently dominating variants.

With Evusheld no longer an option, the CDC on Friday updated information for immunocompromised people.

Besides staying up to date on their vaccinations, those people should wear high-quality and well-fitting masks, practice socially distancing, improve indoor ventilation, and wash their hands frequently. Immunocompromised people should also develop a “care plan” that includes immediate testing if they think they’ve been exposed to COVID.

Show Sources

FDA. “FDA announces Evusheld is not currently authorized for emergency use in the U.S.”

AstraZeneca. “Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld”

FDA. “FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region”

CDC. “Information for Persons Who Are Immunocompromised Regarding Prevention and Treatment of SARS-CoV-2 Infection in the Context of Currently Circulating Omicron Sublineages — United States, January 2023”

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