EU Medicines Regulator Recommends AstraZeneca's Drug for COVID Prevention

By Reuters Staff

March 25, 2022

(Reuters) - The European Medicines Agency on Thursday recommended the use of AstraZeneca Plc's antibody drug for preventing COVID-19 infections at a time the region faces an increase in cases and stagnation in adult vaccinations.

The EMA said the drug, Evusheld (tixagevimab/cilgavimab), should be used in adults and adolescents above the age of 12 who were not exposed to the virus.

In comparison, other antibody drugs made by Regeneron Pharmaceuticals Inc, Eli Lilly and Co, and partners GlaxoSmithKline and Vir Biotechnology have already been approved to treat COVID-19 patients.

Regeneron's antibody drug has been approved in Europe to also prevent COVID-19 infections.

AstraZeneca's COVID drug could be used for preventing infections in people whose immune system is too weak to respond to vaccines, helping ease the pandemic burden on healthcare systems.

While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, Evusheld contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.

Infections in Europe are on a sharp rise again this month, with the adult vaccination rate stagnating at a little over 83%.

AstraZeneca said on Monday that Evusheld retained neutralising activity against three Omicron coronavirus sublineages, including the highly contagious BA.2, in an independent lab study in mice that was published ahead of peer review on the bioRxiv website.

The therapy was found to cut the risk of developing symptomatic COVID-19 by 77% in clinical trials, with protection lasting for at least six months. It has also been shown to prevent disease progression when given soon after infection.

Reuters reported on the EMA decision on Wednesday, which is expected to be swiftly followed by a confirmation by the European Commission.

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