Italian Medicines Agency Agenzia Italiana del Farmaco

CTS expands Evusheld prescription criteria for pre-exposure prophylaxis in subjects at high risk of severe Covid-19 disease - CTS expands Evusheld prescription criteria for pre-exposure prophylaxis in subjects at high risk of severe Covid-19 disease

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CTS expands Evusheld prescription criteria for pre-exposure prophylaxis in subjects at high risk of severe Covid-19 disease

On 07/06/2022, AIFA's Scientific Technical Committee (CTS) extended the possibility of treatment with the tixagevimab/cilgavimab combination (Evusheld) for pre-exposure prophylaxis in subjects at high risk of severe COVID-19 disease. Such prophylaxis may be prescribed, within the already identified risk categories, without the need for serology for anti-SARS-CoV-2 antibodies. 

The Commission has decided to leave to the clinician the decision of treatment with Evusheld on the basis of the evaluation of the individual patient, in consideration of the impossibility of defining a reliable cut-off regarding the presence or absence of protection based on a specific level of antibodies, and in consideration of the fact that the selection of patients at risk is in any case left to a highly specialized field.

The CTS will continue to evaluate the efficacy and duration of the protective effect of the monoclonal antibody combination also with regard to the evolution of the epidemiological picture and the circulating variants, in order to adapt the strategy to the epidemiological situation and to the evidence gradually acquired.


Published on: 09 June 2022

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