Monoclonal antibodies, distribution in Italy entrusted to the Extraordinary Commissioner Arcuri

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08 February 2021 The distribution of drugs with monoclonal antibodies is carried out by the extraordinary Commissioner for the implementation and coordination of measures to contain and combat the epidemiological emergency COVID-19.  

This is foreseen by the decree of the Minister of Health 'Authorization for the temporary distribution of medicines based on monoclonal antibodies for the treatment of COVID-19' published in the official gazette. 

In particular, the temporary distribution of the monoclonal antibody bamlanivimab and the association of monoclonal antibodies bamlanivimab-etesevimab, produced by the pharmaceutical company Eli Lilly, and the association of monoclonal antibodies casirivimab-imdevimab of the pharmaceutical company Regeneron / Roche are authorized. deals with the two monoclonal antibody drugs for the treatment of Covid-19, which had received the green light on February 3 from Aifa, that of the US company Regeneron Pharmaceuticals and that of Eli Lilly of Latina.

The only two drugs in the world authorized so far, this

can be used for the treatment of a limited category of Coronavirus patients.

These are non-hospitalized people who, even with mild / moderate disease (within 72 hours of symptoms), are at high risk of developing a severe form of Covid-19.

These therapies will be administered by intravenous infusion to be carried out, the experts of the Italian Medicines Agency indicate, in a time of 60 minutes (followed by another 60 minutes of observation) and "in settings that allow a prompt and appropriate management of any adverse reactions serious ".

The

treatment with monoclonal antibodies, highlights the opinion of Cts Aifa, must be represented "only by subjects over the age of 12, positive for Sars-CoV-2, not hospitalized for Covid-19, not in oxygen therapy for Covid-19, with mild-to-moderate symptoms of recent onset (and in any case for no more than 10 days) and the presence of at least one of the risk factors (or at least 2 if one of them is over 65) "such as chronic kidney disease, uncontrolled diabetes, immunodeficiencies.

The choice regarding the "methods of prescribing monoclonal antibodies, as well as the definition of the specific organizational aspects, can be left to the individual Regions".