Oct 11 (Reuters) - The European Union's drug regulator said
it was evaluating a marketing authorisation for an antibody
cocktail developed by Roche and Regeneron for
treatment and prevention of COVID-19 in people above the age of
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
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 hospitalisation 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
Marketing authorisation 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.
(Reporting by Yadarisa Shabong in Bengaluru; Editing by