FDAnews
www.fdanews.com/articles/207052-astrazenecas-evusheld-wins-uk-nod-for-preventing-covid-19

AstraZeneca’s Evusheld Wins UK Nod for Preventing COVID-19

March 21, 2022

The UK’s Medicines and Healthcare products Regulatory Agency has approved AstraZeneca’s Evusheld (tixagevimab and cilgavimab) for the prevention of COVID-19, making it the first antibody combination cleared in the country for the indication.

The authorization was supported by results from a phase 3 study in 5,172 patients, which showed a 77 percent reduction in the risk of contracting symptomatic COVID-19 in those who received the drug compared with those given a placebo.

One dose of Evusheld confers protection for an estimated six months for immunocompromised individuals and others who are unlikely to mount an adequate response to COVID-19 vaccination, AstraZeneca said.

Evusheld received Emergency Use Authorization from the FDA in December 2021.

View today's stories