AZ's Antibody First to Be Cleared by FDA for COVID Prevention
AstraZeneca's Evusheld, a long-acting antibody combination previously known as AZD7442 (tixagevimab and cilgavimab), has received emergency use authorization (EUA) from the US FDA for the prevention of COVID-19. This authorization is specifically for adults and adolescents aged 12 and older, weighing at least 40kg, who have compromised immune systems and may not respond adequately to COVID-19 vaccines or cannot receive them for medical reasons.
The approval is based on the PROVENT study, which involved 5,200 patients and demonstrated that Evusheld reduced the risk of developing symptomatic COVID-19 by 77% compared to a placebo. The study followed patients for six months after a single intramuscular injection of Evusheld, with AstraZeneca suggesting the protection could last up to 12 months.
This development is particularly significant for individuals who remain at high risk of COVID-19 despite vaccination efforts. Myron Levin, the lead investigator of the PROVENT study from the University of Colorado School of Medicine, emphasized the importance of Evusheld as a new, easily-administered option offering long-lasting protection.
In addition to the PROVENT study, Evusheld is also being evaluated in the STORM CHASER trial to assess its effectiveness in preventing COVID-19 among individuals exposed to someone with a confirmed SARS-CoV-2 infection. Preliminary results from this trial have been inconclusive.
AstraZeneca has also presented laboratory data indicating that Evusheld neutralizes emerging SARS-CoV-2 variants, including Delta, with no evidence of the Omicron strain escaping its effects. This positions Evusheld as a promising tool in the ongoing battle against COVID-19, especially for those with compromised immunity.
The US government has placed an order for 700,000 doses of Evusheld, valued at over $726 million, following the FDA's EUA. The antibody is also under a rolling review in the EU, highlighting its potential global impact in preventing COVID-19 among vulnerable populations.