• Aifa: ok with monoclonals, considered an emergency situation

  • Aifa green light for 2 monoclonal antibodies in Italy

  • Pressing of Hope on monoclonals, today an extraordinary meeting of the Aifa

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by Tiziana Di Giovannandrea

06 February 2021 The Minister of Health, Roberto Speranza, has signed the decree authorizing the distribution of monoclonal antibodies.



"On the basis of the indications of the Italian Medicines Agency and the opinion of the Superior Health Council, I signed the decree authorizing the extraordinary distribution of monoclonal antibodies", he wrote on Twitter.

"So - continues the post - together with vaccines we have one more chance to fight Covid".


On the basis of the indications of the Italian Medicines Agency and the opinion of the Superior Health Council I signed the decree authorizing the distribution of monoclonal antibodies.

So we have, together with vaccines, one more chance to fight covid 19.

- Roberto Speranza (@robersperanza) February 6, 2021 These are 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 so far authorized.



This

therapeutic option

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

candidate population for

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".