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Japan health Ministry nod Evusheld of AstraZeneca

 

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Japan health Ministry nod Evusheld of AstraZeneca

The Japan health Ministry has approved Evusheld of AstraZeneca for COVID-19. Evusheld is an investigational medicine used in adults and adolescents for pre-exposure prophylaxis for prevention of COVID-19.

In December 2021, the U.S. Food and Drug Administration had approved AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together)for emergency use for prophylaxis of COVID-19. And followed by March 2022, EMA's human medicines committee (CHMP) has recommended granting a marketing authorisation for Evusheld.

In June 2022, The Results of clinical trials published in The Lancet Respiratory Medicine support benefits of Evusheld in the outpatient treatment of mild-to-moderate COVID-19. The trial was conducted in 95 sites in the US, Latin America, Europe and Japan. 903 participants were randomised to receive either Evusheld or saline placebo, administered in two separate, sequential IM injections.

In Japan, the drug is approved for people with compromised immune systems, such as cancer, who would see little or no benefits from typical vaccines. Its efficacy is said to last around six months.