European Medicines Agency begins evaluating new treatment for COVID-19

AMSTERDAM (AP) – The European Union’s pharmaceutical authority said on Thursday it was evaluating a new drug to treat COVID-19 patients who do not need supplemental oxygen but are at increased risk of developing severe symptoms of the disease.

Xevudy, developed by US company Vir Biotechnology Inc. and UK company GlaxoSmithKline, is a so-called monoclonal antibody treatment – a lab-made version of antibodies that block viruses that help fight infections.

Antibody treatments remain one of the few therapies that can lessen the worst effects of COVID-19, and they are the only option available for people with mild to moderate cases who are not yet in hospital.

The European Medicines Agency said it has started evaluating a marketing authorization application and could issue an opinion within two months, if the data submitted with the application is strong enough.

The agency’s Committee for Medicinal Products for Human Use has already reviewed some data on Xevudy in an ongoing 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 authorization of two other monoclonal antibody treatments – a combination of casirivimab and imdevimab, and the drug regdanvimab. He said both significantly reduce the risk of hospitalization and death in patients vulnerable to severe COVID-19.


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