Evusheld (formerly known as AZD7442) combines tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. The antibody combination was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.
Evusheld gained emergency use authorization in the US for prevention of COVID-19 in December 2021, offering an alternative to vaccination for those who cannot receive a vaccine or do not mount a sufficient immune response (it has also now been authorized for prevention in the EU and a number of other countries).
The Japanese approval, however, marks the first approval for both prevention and treatment. In treatment, trials showed the combination ‘significantly reduced’ the relative risk of COVID-19 progressing to severe illness or death.
AstraZeneca continues to progress submissions for Evusheld for both prevention and treatment around the world.
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.”
Japanese approvals
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.