The European Commission, upon the advice of the European Medicines Agency (EMA), has authorized the following medicines containing monoclonal antibodies, alone or in combination, against the spike protein of the SARS-CoV-2 virus:

• casirivimab-imdevimab combination called Ronapreve (of the pharmaceutical company Regeneron/Roche) for the treatment and prevention of COVID-19;
• regdanvimab called Regkirona (of the pharmaceutical company Celltrion Healthcare Hungary Kft) for the treatment of COVID-19;
• sotrovimab called Xevudy (of the company GSK) for the treatment of COVID-19;
• tixagevimab-cilgavimab combination called Evusheld (of the pharmaceutical company AstraZeneca) for the pre-exposure prophylaxis of COVID-19 and in the early treatment of SARS-CoV-2 infected subjects at risk of a severe form of COVID-19.

Italy has implemented the EU authorizations with Resolution no. 155 and no. 156 of 25 November 2021 (Official Gazette no. 282 of 26 November 2021) for Ronapreve and Regkirona respectively, no. 169 of 23 December 2021 (Official Gazette no. 305 of 24 December 2021) for Xevudy and no. 53 of 13 April 2022 (Official Gazette no. 88 of 14 April 2022) for Evusheld, 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 on posology and method of administration of Ronapreve").

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 adult and pediatric patients over 12 years of age hospitalized for COVID-19, also on conventional oxygen therapy (not high-flow and not on mechanical ventilation), but with negative serology for SARS-CoV-2 anti-Spike IgG antibodies, for scientific rationale only.

The bamlanivimab-etesevimab monoclonal antibody combination (of the pharmaceutical company Eli Lilly) for the treatment of COVID-19 has not yet received approval from the European Commission. In Italy it has 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 through the Decree of the Minister of Health of 12 July 2021 published in the Official Gazette no. 180 of 29 July 2021 (extension of the decree of 6 February 2021). With Resolution no. 318 of 17 March 2021, published in the Official Gazette no. 66 of 17 March 2021, AIFA defines the terms and conditions of use of bamlanivimab-etesevimab.

The authorization for the temporary use of the monoclonal antibody bamlanivimab in monotherapy (Resolution no. 274 of 6 February 2021, published in the Official Gazette no. 58 of 9 March 2021) was revoked with Resolution no. 557 of 9 March 2021, published in the Official Gazette no. 108 of 7 May 2021. The use remains permitted of of bamlanivimab in extemporaneous combination with etesemivab. AIFA resolution no. 85 of 11 February 2022, published in the Official Gazette no. 38 of 15 February 2022, extends to 18 months the validity of bamlanivimab vials stored at a temperature between 2°C and 8°C.

On 25 March 2022, EMA granted the marketing authorization (no. EU/1/22/1651/001) to the combination of monoclonal antibodies tixagevimab-cilgavimab called Evusheld (of the pharmaceutical company AstraZeneca), which is therefore valid throughout the European Union. In Italy, Evusheld was authorized for the pre-exposure prophylaxis of SARS-COV-2 infection on a temporary basis with the Decree of the Minister of Health of 20 January 2022, published in the Official Gazette no. 22 of 28 January 2022. AIFA Resolution no. 87 of 15 February 2022, published in the Official Gazette no. 42 of 19 February 2022, defines the terms and conditions of use of Evusheld.

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.
The data sheets relating to all the drugs monitored are available in the lists published on the page "Updated list of web-based Registries and Therapeutic Plans".

Please find below the AIFA Resolutions and the links to the Medicines Database. Furthermore, the attachments are available with information on bamlanivimab-etesevimab and for Evusheld, aimed at patients and healthcare professionals.
Weekly reports are also available with the results of monitoring through the AIFA registry developed in implementation of the Decree of the Ministry of Health of 6 February 2021.