Japan Approves and Purchases Antibody Combo for Prevention and Treatment of COVID-19
United Kingdom-based AstraZeneca plc announced today that Evusheld, a long-acting antibody combination, has been approved in Japan for both prevention and treatment of symptomatic COVID-19 disease caused by SARS-CoV-2 infection.
The decision by Japan's Ministry of Health, Labour and Welfare (MHLW) marks the first global marketing approval for Evusheld (tixagevimab and cilgavimab) as a treatment for COVID-19.
In prevention, the 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 for 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 the SARS-CoV-2 coronavirus.
In treatment, Evusheld is approved for adults and adolescents (12 years of age and older weighing at least 40kg) with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen.
Additionally, the Japanese government has agreed to purchase 300,000 units of Evusheld.
Itaru Matsumura, M.D., Ph.D. Professor & Chairman, Department of Hematology & Rheumatology, Kindai University Faculty of Medicine, Otsuka, Japan, commented in a press release issued on August 30, 2022, "Despite the progress of vaccinations and stringent safety precautions, there is a very large number of new (COVID-19) infections in Japan."
"The approval of Evusheld is expected to provide a non-vaccine prophylactic option for those who cannot expect a full immune response from COVID-19 vaccination, such as patients with blood cancers."
The primary data supporting the Evusheld pre-exposure prophylaxis authorizations are from the ongoing PROVENT Phase III pre-exposure prevention trial, published in The New England Journal of Medicine, which showed a statistically significant reduction (77% at primary analysis, 83% at median six-month analysis) in the risk of developing symptomatic COVID-19 compared to placebo, with protection from the virus lasting six months.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added, "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 authorized for COVID-19 prevention and treatment, allowing us to help protect even more vulnerable patients such as the immunocompromised from this devastating disease."
Evusheld is also authorized for use for pre-exposure prophylaxis of COVID-19 in the USA (FDA-emergency use), the EU, and many other countries.
Japan's daily coronavirus totaled 95,916 cases on August 29, 2022, falling below 100,000 for the first time in six weeks.
Additional monoclonal antibody news is posted at CoronavirusToday.
Note: This AZ announcement was manually translated and curated for mobile readership.