The U.S. Food and Drug Administration (FDA) has revoked the emergency use license for Evusheld's antibody-based drug for the prevention and treatment of coronavirus, according to drugmaker ASTRAZENECA.
The decision was made due to the persistent high level of spread of covid-19 variants , in the treatment and prevention of which the drug "does not retain neutralization in vitro (under artificial conditions. -)".
The FDA will consider license reinstatement if the country's prevalence of these options drops to 90% or less on a permanent basis. The companies recommended proper storage of Evusheld in case of a higher spread of vaccine-susceptible subspecies of the coronavirus.
In other countries where the drug has already received a license, it is also allowed, notes AstraZeneca, including the European Union and Japan.
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Evusheld, according to company research, does not neutralize the sub-variants of "omicron" BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and XBB.1.5 .1 At the same time, according to modeling data from the Centers for Disease Control and Prevention (CDC), the combined proportion of COVID-19 cases caused by these subspecies now exceeds 90% in the United States.
The FDA approved the drug for emergency use in December 2021. In early January last year, the Russian Ministry of HEALTH allowed its circulation in the country, and at the end of November, Evusheld received a registration certificate in RUSSIA.
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