Citing data showing tixagevimab/cilgavimab (Evusheld) is unlikely to be active against certain recent SARS-CoV-2 variants, including XBB.1.5, the Food & Drug Administration (FDA) announced on Jan. 26 that the treatment is no longer authorized for use in the U.S.
New CDC data project that XBB.1.5 and related SARS-CoV-2 variants are responsible for the majority of current infections, rendering Evusheld unlikely to protect patients against the most common circulating variants. Fortunately, other available treatment options are expected to be effective against these variants.
The FDA will continue to work with the Administration for Strategic Preparedness and Response, the CDC and the National Institutes of Health to monitor variants that may impact the therapies authorized for use. The FDA will also monitor trends and update its website. The ACR will continue communicating with the FDA on this issue. Contact [email protected] with questions.
