FDA Revokes Authorization for AstraZeneca’s COVID-19 Treatment Evusheld

The US Food and Drug Administration (FDA) has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralization against,” AstraZeneca said in a statement.

“The FDA has notified AstraZeneca that the Agency will make a determination about reinstating authorization of Evusheld if the national prevalence of resistant variants decreases to 90% or less on a sustained basis. The US government recommends all Evusheld product be retained and properly stored in the event that variants susceptible to Evusheld, including those currently circulating at lower prevalence, become more prevalent in the future,” the company added.

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FDA said that it had withdrawn the approval for the use of Evusheld because at least 90 percent of infections are now caused by sublineages that cannot be neutralized by the treatment.

“Based on in vitro pseudovirus assay laboratory data, Evusheld does not neutralize Omicron subvariants 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 The combined proportion of COVID-19 cases caused by these subvariants is currently greater than 90% in the US, according to the Centers for Disease Control and Prevention (CDC) Nowcast modelling data,” AstraZeneca said.

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