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.
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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.
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By GlobalDataEvusheld 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.
