AstraZeneca nabs EUA for COVID PrEP drug

Dec. 9, 2021

The U.S. FDA has issued an emergency use authorization for AstraZeneca’s long-acting antibody cocktail, Evusheld, for pre-exposure prophylaxis (PrEP) against COVID-19 in individuals with moderate to severe immune compromise.

Evusheld is the first injectable monoclonal antibody cocktail authorized for long-term prevention of COVID among people with weakened immune systems before they have been exposed to the coronavirus.

The treatment, which involves preventative injections as often as every six months, is authorized for individuals who are immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended.

Pivotal phase 3 data from a large placebo-controlled clinical trial demonstrated that the cocktail is about 83% effective at preventing symptomatic disease.

According to AstraZeneca, the first doses are "expected to become available very soon."