FDA Update: Evusheld Not Currently Authorized For Emergency Use in U.S.

The U.S. Food and Drug Administration (FDA) on Jan. 26 announced that Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for emergency use against COVID-19 in the U.S. until further notice by the Agency.

The FDA revised the scope of the Emergency Use Authorization (EUA) for Evusheld "to limit the use of EVUSHELD for pre-exposure prophylaxis of COVID-19 in the United States only when, based on available information including variant susceptibility to EVUSHELD and national variant frequencies, the combined frequency of non-susceptible variants nationally is less than or equal to 90%."

The Agency went on to say that the decision to limit the use of Evusheld "prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product."

The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future.

Read the full letter for more information.

Clinical Topics: COVID-19 Hub, Prevention

Keywords: ACC Advocacy, SARS-CoV-2, COVID-19, United States Food and Drug Administration, Pre-Exposure Prophylaxis, Drug-Related Side Effects and Adverse Reactions, Pharmaceutical Preparations, Hypersensitivity

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