Xevudy, developed by U.S. company Vir Biotechnology Inc. and
Britain-based GlaxoSmithKline, is a so-called monoclonal antibody treatment — a
laboratory-made version of virus-blocking antibodies that help fight off
infections.
Antibody treatments remain one of a handful of therapies
that can blunt the worst effects of COVID-19, and they are the only option
available to people with mild-to-moderate cases who aren’t yet in the hospital.
The European Medicines Agency said it has begun evaluating
an application for marketing authorization and could issue an opinion within
two months, if the data submitted with the application is sufficiently robust.
The agency’s human medicines committee already reviewed some
data on Xevudy during a rolling review. The data came from laboratory and
animal studies, and included information on the quality of the drug.
The announcement came a week after the European Medicines
Agency r ecommended the authorization of two other monoclonal antibody
treatments — a combination of casirivimab and imdevimab, and the drug
regdanvimab. It said both were proven to significantly reduce the risk of
hospitalization and death in patients vulnerable to serious COVID-19.
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