AstraZeneca's Evusheld Approved for Covid-19 Treatment in Japan
30 August 2022 - 2:50PM
Dow Jones News
By Joe Hoppe
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.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
August 30, 2022 08:35 ET (12:35 GMT)
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