FDA Revokes Emergency Use Authorization for Evusheld Due to Variant Ineffectiveness

Key Insights

• The FDA has revoked the emergency use authorization for Evusheld (tixagevimab/cilgavimab) in the U.S. due to its reduced efficacy against emerging SARS-CoV-2 variants.
• Recent data indicates that Evusheld is unlikely to be effective against current dominant variants, such as XBB.1.5, which account for the majority of new infections.
• The decision was based on updated CDC projections showing the prevalence of variants against which Evusheld offers limited protection.

The Food and Drug Administration (FDA) has announced the revocation of the emergency use authorization (EUA) for Evusheld (tixagevimab/cilgavimab) in the United States, effective January 26. This decision follows data indicating that Evusheld is unlikely to be active against several recent SARS-CoV-2 variants, including the XBB.1.5 variant.

According to the FDA, the increasing prevalence of variants against which Evusheld offers limited protection prompted the revocation. New data from the Centers for Disease Control and Prevention (CDC) projects that XBB.1.5 and related SARS-CoV-2 variants are responsible for the majority of current infections. This renders Evusheld unlikely to protect patients against the most common circulating variants.

Evusheld, a combination of two monoclonal antibodies, had been authorized for emergency use in certain populations at high risk for severe COVID-19. However, the emergence and rapid spread of new variants have challenged the efficacy of several monoclonal antibody treatments.

While Evusheld is no longer authorized, other treatment options for COVID-19 are expected to remain effective against the currently circulating variants. Healthcare providers are advised to consider these alternative treatments when managing COVID-19 in their patients.