AMSTERDAM: The European Union’s medicines authority said Thursday that it is evaluating a new drug for treating COVID-19 patients who do not require extra oxygen but are at increased risk of developing severe symptoms of the disease.
Xevudy, developed by US 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 recommended 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.