Evusheld, an antibody cocktail drug manufactured by AstraZeneca (NASDAQ:AZN), has been granted its first global authorization as a COVID-19 treatment, the company reported. Evusheld, a combination of tixagevimab and cilgavimab, has been granted permission in Japan for the prevention of symptomatic disease caused by the SARS-CoV-2 infection (pre-exposure prophylaxis) and the treatment of sickness that has already shown itself.
Until this point, the use of Evusheld in pre-exposure prophylaxis for COVID-19 in particular high-risk populations in Europe, the United States, and some other countries was approved.
Evusheld is approved for use in the prevention of COVID infection in adults and adolescents in Japan who are at least 12 years old and weigh at least 40 kilograms but are not candidates for COVID vaccination and who may not have a sufficient response to a COVID-19 vaccine due to immunodeficiencies. Evusheld is a therapy licensed for adults and adolescents at high risk of developing a severe infection but does not require additional oxygen.
A deal to purchase 300,000 units of Evusheld has been reached between AstraZeneca (NASDAQ:AZN) and the government of Japan. AstraZeneca anticipates that regulatory applications related to the therapeutic indication will be submitted in several countries soon.
AstraZeneca’s (NASDAQ:AZN) share price has increased by 8.8% this year, whereas the overall pharmaceutical industry decreased by 2.6% during the same time frame.
The data from the phase III studies of preventative and outpatient therapy called PROVENT and TACKLE were used as the basis for the approval in Japan.
According to the PROVENT preventive research findings, taking one dose of Evusheld containing 300 mg intramuscularly reduced the likelihood of acquiring symptomatic COVID-19 by 77 percent compared to taking placebo at the primary and 83 percent at the follow-up analysis. The results of the TACKLE outpatient treatment study showed that a single dose of Evusheld containing 600 milligrams, administered intramuscularly, resulted in a 50% reduction in the risk of developing severe COVID-19 or death (from any cause) in outpatients who had been symptomatic for seven days or less. The placebo group experienced no such reduction in risk.
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