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EU medicines agency reviews approval of Coronavirus drug

by Haruna Gimba
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By Asmau Ahmad with agency report

The European Medicines Agency (EMA) said that it is examining the approval of another Coronavirus drug.

The Swiss pharmaceutical company Roche has submitted an application for approval of its antibody therapy Ronapreve, the EMA announced this in Amsterdam, Netherland.

The drug, which consists of two active ingredients, casirivimab and imdevimab and was co-produced by the U.S. manufacturer Regeneron Pharmaceuticals.

The drug which is intended to treat people aged 12 and over who are infected with the Coronavirus and have a high risk of a severe infection.

In addition, according to the manufacturers, the drug can also be used in people who have an acute risk of infection, for example because they live in a household with an infected person.

Only recently, the World Health Organisation (WHO) recommended the cocktail of casirivimab and imdevimab for the prevention of severe COVID-19 infection in at-risk patients.

In Germany, this antibody combinationis already used in special cases for Coronavirus patients.

The EMA experts are now evaluating all the data presented and weighing up the advantages and disadvantages of the preparation,a result is expected in two months.

The experts had already examined the manufacturer’s research results before it submitted an official application, this shortens the approval procedure.

So far, only the drug remdesivir has been approved in the EU as a special Coronavirus drug.

At present, approval procedures are under way for a total of five preparations.

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