The EMA supports the use of the drug Evusheld to prevent COVID-19

The Hague, 24 Mar The European Medicines Agency (EMA) on Thursday endorsed the use of the drug Evusheld, composed of two monoclonal antibodies developed by the pharmaceutical company AstraZeneca for the prevention of COVID-19 in people over 12 years of age before a possible exposure to SARS-CoV-2, the virus that causes this disease. The EMA Committee for Human Medicinal Products (CHMP) recommended that the European Commission authorize the marketing of Evusheld, composed of the active substances tixagevimab and cilgavimab, two monoclonal antibodies designed to bind to the spike protein of the virus that causes COVID-19 at two different points. “When antibodies in Evusheld attach to the spike protein, the virus cannot enter cells to multiply and cannot cause COVID-19 infection,” the agency notes. The CHMP evaluated data from a clinical study involving more than 5,000 people and which showed that this drug, given in two injections of 150 mg each of the monoclonal antibodies, reduced the risk of COVID-19 infection by 77%. The duration of protection against the virus is estimated to be at least six months and the drug should only be administered to people over 12 years of age with a weight of at least 40 kg, although the data from the analyzed study were collected before the appearance of the omicron variant and its subvariant, so that they may be less sensitive to this preparation . The agency will assess in the coming weeks whether an alternative dosing regimen might be appropriate for the prevention of COVID-19 resulting from emerging variants. The EMA believes that this drug is, in addition to being effective, safe, since its side effects were generally mild, with a small number of people reporting injection-site reactions or hypersensitivity. This cocktail could be key in protecting people with an immunocompromised system, where the COVID-19 vaccines available so far have not had the desired effect in protecting against this disease. CHIEF go/cat/ads (More information about the European Union at euroefe.euractiv.es)