The European Medicines Agency (EMA) announced on Thursday that it has started examining its application for marketing authorization for Xevuda (sotrovimab) against COVID-19.
The drug, developed by the British company GlaxoSmithKline and the American company Vir BioTechnology, is intended for those infected who do not need oxygen support, but are at increased risk of a serious course of the disease, the agency AP wrote.
Xuvedy It works on the basis of monoclonal antibodies of laboratory-produced antibodies, which have the ability to recognize and attach to a specific structure, in this case to the so-called spike protein, which covers the SARS-CoV-2 virus, to prevent the virus from entering the cells of the human body.Read also ECDC: Antibiotic use in Europe fell during the 2020 pandemic
Treatment with such antibodies is the only option available for people with mild to moderate covid symptoms before they end up in hospital.
EMA said on Thursday that it could issue an opinion on the application to withdraw the sale of Xevuda within two months if the data provided by the companies is sufficiently convincing. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has already considered some data on this medicine in the so-called interim evaluation, recalls AP.Read also The Lancet: The Indian Covaxin vaccine is “highly effective” against covid
The assessment of Xevuda’s assessment came a week after the EMA recommended the authorization of two other anti-monoclonal antibodies, also based on monoclonal antibodies, Ronapreve and Regkirona. The EMA stated that both drugs have been shown to significantly reduce the risk of hospitalization and death in those at risk of severe COVID-19 disease.
Source: Pravda – Veda a technika by vat.pravda.sk.
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