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September 19, 2022

EMA CHMP recommends authorisation of AstraZeneca’s Evusheld for Covid-19

The positive opinion is based on data obtained from the Phase III TACKLE trial of Evusheld.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU).

This therapy is intended to treat adult and adolescent Covid-19 patients aged 12 years and above, who do not need additional oxygen and are at greater disease progression risk.

In the region, the dosage advised for usage is 300mg separate, intramuscular (IM) injections of tixagevimab and cilgavimab, given in a sequential manner.

The EMA CHMP positive opinion is based on findings from the double-blind, randomised, placebo-controlled, multicentre Phase III TACKLE clinical trial of IM dose of Evusheld.

According to the findings, the therapy provided clinically and statistically significant protection against Covid-19 progression to severe disease or mortality from any cause versus placebo. 

Additionally, in the trial, the antibody cocktail was found to be well-tolerated.

Evusheld is a cocktail of two long-acting antibodies, tixagevimab and cilgavimab. 

These antibodies are obtained from B-cells of convalescent Covid-19 patients.

AstraZeneca Vaccines and Immune Therapies executive vice-president Iskra Reic said: “Evusheld has already made an important difference around the world helping prevent Covid-19 infections in vulnerable populations who can’t mount an adequate response to Covid-19 vaccination. 

“This positive CHMP opinion underscores Evusheld’s potential as a Covid-19 treatment for patients at increased risk of progressing to severe disease.”

The combination therapy was also found to retain in vitro neutralisation of SARS-CoV-2 virus’ Omicron BA.5 variant, the company noted.

In March this year, Evusheld received marketing authorisation in the EU to prevent Covid-19 in adults and adolescents aged 12 years and above.

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