Green light to the antiviral anti-COVID Evusheld for over 12 years

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The European Medicines Agency (EMA) recommends the marketing authorization of the drug Evusheld, from AstraZeneca, to prevent COVID-19 in people over 12 years of age before possible exposure to the coronavirus.

Evusheld is an antiviral drug to combat COVID-19 developed by Astrazeneca, which could soon be available in the member countries of the European Union, since the Committee for Human Medicines (CHMP) of the EMA (European Medicines Agency) has just to recommend granting a marketing authorization to this medicine for the prevention of COVID-19 in adults and adolescents from 12 years of age who weigh at least 40 kilos.

Evusheld combines two monoclonal antibodies – tixagevimab and cilgavimab – that are specifically designed to bind to the spike protein of the coronavirus in two different places and thus prevent the pathogen from entering human cells to multiply and cause COVID-19.

Safe and effective antiviral to prevent COVID-19 and omicron

The favorable evaluation of the EMA has been based on the results of a study in which more than 5,000 people have participated and which has shown that this medicine, administered in two injections of 150 mg of tixagevimab and 150 mg of cilgavimab, reduces the risk of SARS-CoV-2 infection by 77% and that its protection against the coronavirus lasts for a minimum of six months, also being effective against the omicron variant.

The study gave Evusheld or a placebo (injection without the drug) to adults who had never had COVID-19 and had not received a COVID-19 vaccine or other preventive treatment. 0.2% of people who received Evusheld (8 of 3,441) had laboratory-confirmed progression of COVID-19 after treatment, compared to 1.0% (17 of 1,731) of those who received placebo.

The drug was also shown to be safe, as side effects of the drug were found to be generally mild with only a small number of people reporting injection site reactions, or hypersensitivity. For this antiviral to be supplied throughout the European Union, all that remains is for the European Commission to give its approval.

In Spain, currently, the AEMPS points out that the candidates to receive the combination of monoclonal antibodies in Evusheld are adults aged 18 or over with risk conditions that cause immunosuppression in which an inadequate response to vaccination is demonstrated and those for whom vaccination is contraindicated and who are at very high risk of severe SARS-CoV-2 disease.

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