US grants emergency use authorization for AstraZeneca's Evusheld to prevent COVID-19
The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for AstraZeneca's Evusheld. The long-acting antibody combination is intended for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals.
AstraZeneca's Evusheld (tixagevimab and cilgavimab) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). The therapy is designated for the pre-exposure prophylaxis of COVID-19. This includes adults and adolescents aged 12 and older, weighing at least 40kg, who have moderate to severe immune compromise due to medical conditions or immunosuppressive medications, and for whom COVID-19 vaccination may not be recommended.
Evusheld is the only antibody therapy authorized in the US for COVID-19 pre-exposure prophylaxis. It is intended for individuals who may not mount an adequate immune response to vaccination. Approximately seven million people in the US are considered to be immunocompromised and may benefit from this preventative treatment, including those undergoing chemotherapy or taking immunosuppressants post-organ transplant.
Data from the Phase III PROVENT trial indicated that Evusheld significantly reduced the risk of developing symptomatic COVID-19 by 77% to 83% compared to placebo. Protection was shown to last for at least six months with a single dose. AstraZeneca is currently investigating the therapy's efficacy against the Omicron variant.
The company expects the first doses of Evusheld to become available soon. The development of Evusheld is supported by funding from the US government.