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AstraZeneca said today that its long-acting antibody cocktail, Evusheld (tixagevimab and cilgavimab), compared with placebo in a late-stage pre-exposure prophylaxis trial, reduced patients with symptomatic COVID-19 infection six months later.
83% lower risk
.
The results are in line with data from the main analysis published last summer
.
At the time, AstraZeneca said the treatment was able to reduce the risk of symptomatic infection by 77% compared to a placebo
.
There were also no serious illnesses or COVID-19-related deaths among patients treated with Evusheld over a six-month period
.
In contrast, there were five serious cases and two related deaths in the placebo group, AstraZeneca said
.
In the Phase 3 Provent trial, more than 75% of participants were enrolled because their COVID-19 infection was likely to progress to moderate to severe disease
.
The study population included immunocompromised individuals with insufficient responses to existing vaccines
.
AstraZeneca said the therapy was well tolerated and there were no safety concerns during the initial analysis or the six-month analysis period
.
The trial data, published Wednesday in the New England Journal of Medicine, further confirm the use of Evusheld to help prevent both symptomatic and severe COVID-19, Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca, said in a press release.
Clinical evidence, especially for those who fail to develop an adequate antibody response to the vaccine and need additional protection
.
In December, Evusheld received emergency approval from the U.
S.
FDA for the prevention of COVID-19 infection before exposure to the virus
.
Specifically, the U.
S.
FDA authorized Evusheld for use in people with moderately to severely compromised immune systems
.
In addition, people with adverse reactions to the COVID-19 vaccine can also receive Evusheld treatment
.
Previously, the long-acting antibody combination Evusheld has been approved for marketing in the European Union for pre-exposure prophylaxis of the new coronavirus in a wide range of adults and adolescents (12 years and older and weighing 40 kg and above), and has been approved by the UK Medicines and Healthcare Products Administration ( MHRA) was granted a conditional marketing authorization for pre-exposure prophylaxis against COVID-19
.
AstraZeneca had forecast sales of its COVID vaccine would decline in 2022, but some of that loss would be offset by Evusheld
.
As of February, the company had received initial orders for 700,000 doses nationwide, and has since added 1 million more doses to the U.
S.
market
.
Currently, AstraZeneca is applying for emergency use authorization or marketing approval for Evusheld for the prevention and treatment of new crowns worldwide
.