AstraZeneca’s Evusheld Covid-19 Preventative Drug Approved in EU

By Joe Hoppe

AstraZeneca PLC said Monday that its Evusheld long-acting antibody combination has been approved in the European Union for the prevention of the coronavirus in a broad population.

The pharmaceutical major said a Phase 3 trial has been showing that the treatment–a combination of antibodies tixagevimab and cilgavimab–significantly reduces the risk of developing symptomatic Covid-19 with protection lasting at least six months.

The data from the trial showed 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. The treatment also retains its neutralizing activity against the Omicron BA.2 subvariant, which is now the dominant strain in Europe.

Evusheld is already authorized for emergency use in the U.S. and has been granted conditional marketing authorization in the U.K. The company said the treatment would be particularly beneficial for those not adequately protected by a coronavirus vaccine, such as the immunocompromised.

“The EU approval represents an important milestone in our efforts to help prevent Covid-19, and we will continue to work with governments across Europe to make Evusheld available as quickly as possible,” Mene Pangalos, executive vice president of biopharmaceuticals research and development, said.

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