The FDA has withdrawn the emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab with cilgavimab) as a COVID-19 pre-exposure prophylaxis owing to the emergence of new variants.
Evusheld has been found to be ineffective against several omicron subvariants, including 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 XBB.1.5 subvariant is becoming more prevalent in the U.S., accounting for approximately half of COVID-19 infections in the country.
In 2022, AstraZeneca announced that Evusheld reduced the risk of developing symptomatic COVID-19 by about three-quarters in a Phase 3 study.
In 2022, AstraZeneca revealed the results of a Phase 3 study, showing that Evusheld reduced the likelihood of experiencing symptomatic COVID-19 by roughly 75%. The results were summarized in NEJM in an article noting that the antibody cocktail retained some protection against an early omicron variant.From Evush…