EU assesses Regeneron/Roche COVID-19 drug for authorization

The European Union's drug regulator said it was evaluating a marketing authorization for an antibody cocktail developed by Roche and Regeneron for treatment and prevention of COVID-19 in people above the age of 12.

The European Medicines Agency (EMA) said on Monday it will assess the risks and benefits of the drug, called Ronapreve, and it could issue an opinion within two months. The agency has already started a rolling review of the treatment.

Ronapreve has received emergency approval to treat COVID-19 in more than 20 countries including the United Kingdom and the United States. It belongs to a class of drugs called monoclonal antibodies that mimic natural antibodies produced by the body to fight off infections.

The EMA said it was assessing clinical data investigating the effectiveness of the drug in preventing hospitalization in outpatients, and another study looking at effectiveness in preventing COVID-19 in adults and children at risk of infection from a household member diagnosed with the disease.

Gilead's antiviral, remdesivir, is the only COVID-19 treatment that has been approved for use in the European Union.

Marketing authorization has been submitted for other COVID-19 treatments including Lilly's rheumatoid arthritis drug Olumiant, Sobi's Kineret, Celltrion's regdanvimab and arthritis drug tocilizumab, sold by Roche as RoActemra.

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