AstraZeneca PLC said Tuesday that its Evusheld long-acting antibody combination has been approved in Japan for both the prevention and the treatment of coronavirus, the first time it has been approved for treatment.
The pharmaceutical major said the treatment--a combination of antibodies tixagevimab and cilgavimab--has been approved for preventative use in adults and children over 12 that aren't recommended for vaccination. It has further been approved for treatment in adults and children over 12 with risk factors for serious infection.
The Japanese government has agreed to purchase 300,000 units of Evusheld.
Approvals followed Phase 3 trials, in which Evusheld reduced the risk of developing symptomatic Covid-19 by 77% compared with a placebo initially, and an 83% reduction at the six-month mark, the company said.
Another Phase 3 trial found Evusheld significantly reduced the risk of patients with mild-to-moderate coronavirus infection progressing to severe infection or death by 50% compared to a placebo within 29 days.
Evusheld is already authorized for emergency use in the U.S., the E.U. and other countries.
"Evusheld is now the only long-acting antibody combination authorized for both COVID-19 prevention and treatment, allowing us to help protect even more vulnerable patients such as the immunocompromised from this devastating disease," said Mene Pangalos, executive vice president of biopharmaceuticals research and development.
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