AstraZeneca’s Evusheld for COVID-19 treatment receives approval in Japan

AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a longacting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. The decision marks the first global marketing approval for Evusheld as a treatment for

COVID-19. In prevention, Japan’s Ministry of Health, Labour and Welfare (MHLW) granted Evusheld Special Approval for Emergency for adults and adolescents (12 years of age and older weighing at least 40kg). Evusheld is approved for use in those whom SARS-CoV-2 vaccination is not recommended and who may have an inadequate response to a COVID-19 vaccine due to immunodeficiencies. Recipients of Evusheld for prevention should not be currently infected with or have had recent known exposure to a person infected with SARSCoV-2. The Japanese government has agreed to purchase 300,000 units of Evusheld (150mg each of tixagevimab and cilgavimab), and AstraZeneca is working with the government and partners to make first doses available as soon as possible.