USA — Evusheld, a preventative monoclonal antibody treatment for COVID-19, has lost its emergency use authorization in the United States because it is unlikely to be effective against the coronavirus strains currently circulating.

The Food and Drug Administration (FDA) announcement comes just weeks after the agency stated that it did not expect Evusheld to be effective against the XBB.1.5 omicron subvariant, which is responsible for 61 percent of cases in the country, according to the most recent federal data.

Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,” the FDA said in a statement.

According to a press release from AstraZeneca, laboratory data show that Evusheld is ineffective against many omicron subvariants, including the top three circulating in the United States: XBB.1.5, BQ.1.1, and BQ.1.

Evusheld is a combination of two monoclonal antibodies. It was authorized for use in people who are moderately or severely immunocompromised and likely would not have developed a strong immune response from COVID-19 vaccines.

Monoclonal antibodies work by binding to the spike protein on the surface of the SARS-CoV-2 virus, but the virus has evolved, causing changes in this protein and changing how the antibodies work against it.

The FDA’s decision echoes European health regulators’ concerns about the efficacy of monoclonal antibodies like Evusheld against newer variants.

AstraZeneca said it was informed that the FDA will consider reinstating Evusheld authorization if the prevalence of resistant variants in the United States falls to 90% or less on a sustained basis.

The pharmaceutical company intends to continue sharing relevant data about Evusheld and SARS-CoV-2 variants with the FDA and other health authorities.

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.

In November, the US Food and Drug Administration revoked the emergency use authorization for Eli Lilly’s Covid drug bebtelovimab, citing similar concerns.

Evusheld was approved by the FDA in late 2021 to prevent Covid infections in people with weakened immune systems or a history of severe side effects from coronavirus vaccines.

Because these treatments are no longer available, the FDA recommends that patients who develop symptoms of COVID-19 seek treatment with antivirals such as paxlovid, remdesivir, or molnupiravir, which are still expected to be effective in treating infections.

The FDA advised facilities that have Evusheld in stock to keep it instead of disposing of it, as other COVID-19 strains susceptible to the treatment may become prevalent in the future.

AstraZeneca stated that trials for the “next-generation long-acting antibody” are already underway. Lab studies, according to the company, have shown that its current drug candidate is effective against all COVID-19 strains tested to date. The drugmaker hopes to have this medication available by the end of 2023.

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