Green light from the European Medicines Agency Ema for the Evusheld * monoclonal antibody combination, developed by the Anglo-Swedish AstraZeneca for the prevention of Covid-19 in adults and adolescents from 12 years of age (weighing at least 40 kg). The drug is meant to be administered prior to potential exposure to the Sars-CoV-2 virus. The EU regulatory body gave the news of the positive verdict.
EMA’s CHMP Committee for Medicinal Products for Human Use has today expressed a recommendation to grant marketing authorization for the mix of monoclonals tixagevimab and cilgavimab, designed to bind to the Spike protein of Sars-CoV-2 in two different sites. When they do, the virus cannot enter cells to multiply and is unable to cause infection.
The CHMP, reports the EMA in a note, evaluated the data of a study conducted on over 5 thousand people showing that Evusheld, administered in two injections (of 150 milligrams of tixagevimab and 150 mg of cilgavimab), reduced by 77% the risk of Covid infection, with a duration of protection from the virus estimated at at least 6 months.
In the study, adults who had never had Covid and had not received a vaccine or other preventive treatment received Evusheld or a placebo (a dummy injection). In the group given the monoclonal mix, 0.2% (8 of 3,441 people) had laboratory-confirmed Covid infection after treatment, compared with 1% (17 of 1,731) of people who they received the placebo. The safety profile of the drug, EMA continues, was favorable and side effects were generally mild, with a small number of people reporting injection site reactions or hypersensitivity. The CHMP has therefore concluded that the benefits of the medicine are greater than its risks in the approved use and will now send its recommendation to the European Commission “for a quick decision applicable in all EU member states”.
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