FDA withdraws emergency use approval of COVID drug as unlikely

FDA withdraws emergency use approval of COVID drug as unlikely to be effective against new variants

The U.S. Food and Drug Administration announced Thursday that it is withdrawing its emergency use authorization for a COVID-19 antibody therapy as a prevention tool because it is unlikely to be effective against variants currently on the market.

Evusheld, made by Anglo-Swedish pharmaceutical and biotechnology company AstraZeneca, was first approved in December 2021 as pre-exposure prophylaxis against the virus for those who are immunocompromised and less likely to produce antibodies from vaccinations.

However, the FDA said the drug fails to neutralize several Omicron subvariants, including BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, and XBB XBB. 1.5.

According to the Centers for Disease Control and Prevention, these subvariants make up at least an estimated 90% of cases in the United States

“This means that Evusheld is not expected to provide protection against developing COVID-19 when exposed to these variants,” the FDA said in a press release.

“Today’s action to restrict the use of Evusheld prevents patients from being exposed to possible side effects of Evusheld, such as allergic reactions, which can be potentially serious, while less than 10% of the variants circulating in the US that cause infections are susceptible to the product are,” the press release continued.

The FDA has been warning for months that Evusheld may not be very effective, beginning in February 2022 when data showed a higher dose could potentially prevent infections from the omicron subvariants BA.1 and BA.1.1 than the originally approved dose.

PHOTO: The Evusheld injection is seen on March 20, 2022, a COVID-19 treatment people can take before they become symptomatic.

The Evusheld injection is seen on March 20, 2022, a COVID-19 treatment that people can take before they become symptomatic.

Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images, FILE

As recently as January 6 of this year, the FDA said it did not believe Evusehld would be able to neutralize subvariant XBB.1.5 “due to its similarity to variants not neutralized by Evusheld”.

AstraZeneca did not immediately respond to ABC News’ request for comment. In a statement, the pharmaceutical company said it was aware of the decision and was cooperating with the FDA.

“AstraZeneca will continue to work with the FDA and other health authorities to collect, assess and share relevant data on Evusheld and SARS-CoV-2 variants,” the statement said. “Evusheld currently remains approved in other countries where it is approved for pre-exposure prophylaxis and treatment of COVID-19, including the EU and Japan.”

Evusheld is a type of monoclonal antibody treatment, which is an antibody cocktail made in a lab that mimics the antibodies the body makes naturally when fighting the virus.

They bind to the spike protein, which prevents the virus from attaching to and infecting cells.

The FDA said if someone tests positive for COVID-19 and develops symptoms, they should contact their primary care physician and ask for antiviral drugs Paxlovid, molnupriavir, or remdesivir, which work against currently circulating variants, if needed.

Even though Evusheld lost emergency use approval status, the FDA urged vendors not to discard their doses of the drug.

“The U.S. government is recommending facilities and providers with Evusheld to hold all products in case SARS-CoV-2 variants neutralized by Evusheld become more prevalent in the U.S. in the future,” the FDA said in its press release.