Italian Medicines Agency Agenzia Italiana del Farmaco

Uso degli anticorpi monoclonali per COVID-19

Use of monoclonal antibodies for COVID-19

On 12 November 2021, the European Commission, upon the advice of the European Medicines Agency (EMA), authorized the combination of the monoclonal antibodies casirivimab-imdevimab called Ronapreve (of the pharmaceutical company Regeneron/Roche) with the monoclonal antibody regdanvimab called Regkirona (of the pharmaceutical company Celltrion Healthcare Hungary Kft) for treatment and prevention (Ronapreve) and for the treatment (Regkirona) of COVID-19.

Italy has implemented the EU authorizations with Resolution no. 155 and no. 156 of 25 November 2021, published in the Official Gazette no. 282 of 26 November 2021, which classify medicines reimbursed by the National Health Service in non-negotiated C [C(nn)] class and assign the following supply regime: medicine subject to a restrictive medical prescription, to be renewed from time to time, sold to the public on prescription from hospital centers identified by the Regions (RNRL).

Compared to the temporary use previously authorized in Italy, the dosage and method of administration of Ronapreve have been changed (see FAQ in "Related documents").

With Resolution no. 1414 of 25 November 2021, published in the Official Gazette no. 282 of 26 November 2021, Ronapreve was also included in the list of medicines entirely charged to the National Health Service pursuant to Law no. 648 of 23 December 1996, for the treatment of patients hospitalized with COVID-19.

The combination of the monoclonal antibodies bamlanivimab-etesevimab (of the pharmaceutical company Eli Lilly) with the antibody sotrovimab (of the pharmaceutical company GSK) for the treatment of COVID-19 have not yet received EU approval; however, in Italy they have been temporarily authorized through the Decree of the Minister of Health of 6 February 2021 published in the Official Gazette no. 32 of 8 February 2021, and the Decree of the Minister of Health of 12 July 2021 published in the Official Gazette no. 180 of 29 July 2021.

The distribution of the aforementioned medicines is part of the tasks of the extraordinary Commissioner for the COVID-19 emergency, pursuant to Art. 122 of the Decree-law no. 18 of 17 March 2020.

These medicines are subject to additional monitoring, which will allow rapid identification of new safety information. Healthcare professionals are required to report any suspected adverse reactions.
On this page, you can find the currently available weekly reports on monoclonal antibodies, with the results of the monitoring performed through the AIFA registry, in implementation of the Decree of the Ministry of Health of 6 February 2021.

Please find below Annex I – Conditions of use issued by the EMA and the main documents relating to monoclonal antibodies (or their combination) available in Italy.

Monitoring of the monoclonal antibodies for COVID-19

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