To partially counter the news arriving on the epidemiology front, with the numbers of Sars-Cov-2 positives rising continuously, the European Commission’s green light arrives for the combination of casirivimab and imdevimab antibodies with a double indication: treatment of infected patients who are not hospitalized but at high risk of developing the disease and that of people exposed to the virus but not yet positive. The two monoclonal antibodies can therefore be used not only in treatment – as has been the case since last February thanks to the emergency approval of AIFA and has already been done for almost 8 thousand patients – but also in prevention.
The decision comes shortly after the positive opinion of the CHMP, the Committee for Human Medicines, of the European Medicines Agency (EMA), and follows approval by Japan, and conditional approval in the United Kingdom and Australia. . The drug can be administered to adults and adolescents from 12 years onwards, weighing at least 40 kilograms, both in the treatment setting, when patients are at high risk of severe forms of the disease but do not yet require the use of oxygen therapy, both in the preventive one.
The results of the studies
The go-ahead for the antibody combination came after clinical trials demonstrated its ability to reduce both hospitalization or death by 70% and symptom duration by four days (REGN-COV 2067 study) in patients with greater risk of progression to severe forms of the disease not yet hospitalized; and symptomatic infections of 81% in those who were not infected but had been exposed to the virus (REGN-COV 2069 study). The preclinical studies published in recent weeks in Cell and Nature have also demonstrated the effectiveness of the combination, now available for emergency use in 50 countries around the world, even against variants of the virus.
Together with casirivimab and imdevimab, the Commission has given the green light for another monoclonal antibody, regdanvimab. In this case, the indications are for the treatment of patients at greater risk of progression to severe forms of the disease that do not yet require supplemental oxygen and not for prevention. Both are the first monoclonal antibody-based drugs to be recommended as part of the European strategy against the spread of the coronavirus.
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