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AstraZeneca PLC on Tuesday said its Evusheld Covid-19 treatment was approved in Japan for prevention and treatment of symptomatic disease caused by SARS-CoV-2 infection.
The Cambridge-based pharmaceutical firm said the decision by Japan's Ministry of Health, Labour & Welfare represented the first approval globally for Evusheld, a long-acting antibody combination, as a treatment for Covid.
AstraZeneca Executive Vice President Mene Pangalos said: ‘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.’
Kazuhiro Tateda, a professor in the department of Microbiology & Infectious Disease of Toho University, added: ‘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.’
Astra said the approval was based on efficacy and safety data from the Evusheld clinical development programme.
The company said the Japanese government agreed to purchase 300 thousand units of Evusheld, and that it is working with the government and partners to make first doses available as soon as possible.
Shares were down 2.2% at 11,114.00 pence each on Tuesday afternoon in London.
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