EU drug authority examines approval of corona drug

The European Medicines Agency Ema is reviewing the approval of another corona drug.


The Swiss pharmaceutical company Roche has submitted an application for approval of its antibody therapy Ronapreve, the Ema announced on Monday in Amsterdam. The drug, which consists of two active ingredients (casirivimab and imdevimab) and was co-produced by the US manufacturer Regeneron Pharmaceuticals, is intended to treat people aged 12 and over who are infected with the coronavirus and have a high risk of a severe course.

In addition, according to the manufacturer, the agent 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.

The World Health Organization (WHO) recently recommended the cocktail of casirivimab and imdevimab for the prevention of severe Covid 19 disease in infected risk patients. In Germany, this antibody combination is already used in special cases for corona patients.

The Ema experts now evaluate all the data presented and weigh the advantages and disadvantages of the preparation against each other. A result is expected in two months. The experts had already checked the manufacturer’s research results before the manufacturer submitted an official application. This shortens the approval process.

So far, only the drug Remdesivir has been approved as a special corona drug in the EU. A total of five preparations are currently being approved.


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