AstraZeneca’s Evusheld approved in Japan for treatment, prevention of Covid-19

AstraZeneca said on Tuesday that its Evusheld long-acting antibody combination has been approved in Japan for the prevention and treatment of Covid-19.

Evusheld - tixagevimab and cilgavimab, formerly AZD7442 - has been approved for both the prevention and treatment of symptomatic disease caused by SARS-CoV-2 infection. This is the first global marketing approval for Evusheld as a treatment for Covid-19.

As far as prevention is concerned, the combination has been approved for adults and adolescents. It has been approved for use in those for whom SARS-CoV-2 vaccination is not recommended and who may have an inadequate response to a Covid vaccine due to immunodeficiencies. AstraZeneca said recipients of Evusheld for prevention should not be currently infected with or have had recent known exposure to a person infected with SARS-CoV-2.

In treatment, Evusheld has been approved for adults and adolescents with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: "The approvals of Evusheld in Japan represent an important milestone in our ongoing efforts to help combat Covid-19 on all fronts.

"Evusheld is now the only long-acting antibody combination authorised for both Covid-19 prevention and treatment, allowing us to help protect even more vulnerable patients such as the immunocompromised from this devastating disease."

The Japanese government has agreed to buy 300,000 units of Evusheld and AstraZeneca said it is working with the government and partners to make first doses available as soon as possible.