FDA Revises Evusheld EUA Halting Use of the COVID-19 Therapy for Now

Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in the US until further notice, according to the Food and Drug Administration (FDA).

Evusheld is a combination of 2 long-acting monoclonal antibodies designed to bind to distinct sites on the SARS-CoV-2 spike protein. Recent data show that the product is unlikely to be active against currently circulating SARS-CoV-2 variants (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). These variants are the cause of more than 90% of current infections in the US, based on the Centers for Disease Control and Prevention’s (CDC) Nowcast data.

Based on these findings, the FDA has revised the Emergency Use Authorization (EUA) for Evusheld to limit its use to when the combined frequency of nonsusceptible SARS-CoV-2 variants nationally is less than or equal to 90%. The US government recommends that facilities and providers continue to store the product in the event that variants susceptible to Evusheld become more prevalent in the future.

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Alternative therapies such as Paxlovid, Veklury (remdesivir), and Lagevrio (molnupiravir) are expected to work against currently circulating variants. These treatments are authorized or approved to treat patients with mild to moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.

The updated Evusheld fact sheet for health care providers is available here.


  1. Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld. News release. January 26, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/update-on-evusheld-us-eua.html
  2. FDA announces Evusheld is not currently authorized for emergency use in the US. News release. January 26, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us

This article originally appeared on MPR

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