AstraZeneca’s COVID-19 Long-Acting Antibody Combo Snags EUA

The FDA has granted AstraZeneca’s long-acting antibody combination Evusheld an Emergency Use Authorization (EUA) for preventing COVID-19 in adults and children 12 years of age and older with weak immune systems.

The combination tixagevimab/cilgavimab treatment is indicated for people with moderate-to-severe immunocompromise caused by a medical condition or immunosuppressive drugs who may be unable to mount a proper immune response to a COVID-19 vaccine, as well as those who shouldn’t receive a coronavirus vaccine at all.

Evusheld’s EUA was supported by data from a phase 3 study, which showed the combination reduced the risk of developing symptomatic COVID-19 by 77 percent when compared with a placebo. The late-stage trial enrolled nearly 5,200 participants.