Top pharma group AstraZeneca said its Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting 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, said the statement from AstraZeneca. 

 

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, it stated.

 

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.

 

Kazuhiro Tateda, Professor at Department of Microbiology and Infectious Disease, Toho University, Tokyo, said: "Covid-19 continues to have a significant impact on our daily lives in Japan. Many people, including older adults, patients with comorbidities, and immunocompromised patients, remain at risk for poor outcomes from severe Covid attack."

 

"Evusheld will be a much-needed new option, offering long-term protection for those who do not achieve an adequate immune response after vaccination and helping prevent severe disease and death in those who do become infected," he added.

 

Itaru Matsumura, Professor and Chairman, Department of Hematology & Rheumatology, Kindai University Faculty of Medicine, Otsuka, said: "Despite the progress of vaccinations and stringent safety precautions, there are very large number of new 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." 

 

Following this move, 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.

 

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," he added.-TradeArabia News Service