The United States Food and Drug Administration has withdrawn emergency-use permission for AstraZeneca’s COVID-19 antibody cocktail Evusheld because the medication is unlikely to neutralize the currently prevalent XBB.1.5 subvariant of Omicron.
The FDA had restricted Evusheld’s usage earlier this month for the same reason, and the FDA’s decision on Thursday sent U.S. shares of London-based AstraZeneca down 1.31% to $65.75.
AstraZeneca’s COVID-19 Medication ‘Evusheld’
Since December, Omicron subvariant XBB.1.5 has been quickly spreading throughout the country, accounting for roughly half of all U.S. According to federal data, there were COVID-19 cases last week.
Evusheld was withdrawn from the market by the FDA because it is ineffective against more than 90% of the Covid subvariants that are currently circulating in the United States.
According to CDC data, the omicron XBB.1.5 subvariant, which is adept at avoiding antibodies that stop infection, has rapidly spread in the United States, accounting for 49% of new cases.
Evusheld is likewise ineffective against the subvariants BQ.1, BQ.1.1, and XBB. Versions of Covid that are resistant to Evusheld, when combined with XBB.1.5, currently account for almost 93% of new cases in the United States.
People with weakened immune systems, such as cancer chemotherapy and organ transplant recipients, are among those most vulnerable to severe Covid illness. Because immunizations do not elicit a significant immune response, many people use Evusheld as an additional layer of protection.
The decision to withdraw Evusheld comes more than a month after the FDA yanked bebtelovimab, an antibody therapy since it was ineffective against the BQ.1 and BQ.1.1 subvariants.
According to data from the Health and Human Services Department, just over one million doses of Evusheld have been distributed in the United States since the FDA authorized the injections in December 2021. Approximately 720,000 of those doses have been provided to patients.
More than 7 million adults in the United States have a weakened immune system. According to a CDC review of data from ten states, they accounted for around 12% of Covid hospitalizations despite constituting only 3% of the population.
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Other Coronavirus Treatment That Failed To Pass FDA Standards
Evusheld’s replacement is presently unavailable. The White House Covid task force’s director, Dr. Ashish Jha, has blamed Congress for the declining number of therapies. He claims that the failure of politicians to pass further Covid financing means there is no money to invest in new antibodies.
In November, the US Food and Medication Administration revoked emergency use authorization for Eli Lilly and Company’s COVID-19 drug bebtelovimab, citing similar concerns.
When the researchers examined only blood samples collected the furthest away from when the subjects were diagnosed with Alzheimer’s disease, they discovered that neurogenesis changes occurred 3.5 years before a clinical diagnosis.
Dr. Edina Silajdžić, the study’s joint first author added, “Our findings are extremely important, potentially allowing us to predict the onset of Alzheimer’s early in a non-invasive fashion. This could complement other blood-based biomarkers that reflect the classical signs of the disease, such as the accumulation of amyloid and tau (the ‘flagship’ proteins of Alzheimer’s disease).”
According to the researchers, these discoveries may provide a chance to better understand the changes that occur in the brain during the early stages of Alzheimer’s disease.
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