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Italian Medicines Agency Agenzia Italiana del Farmaco

Definition of optimal use of anti COVID-19 monoclonal antibodies - Definition of optimal use of anti COVID-19 monoclonal antibodies

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Definition of optimal use of anti COVID-19 monoclonal antibodies

Press release n. 658 - AIFA has updated the methods of use of anti COVID-19 monoclonal antibodies in relation to the new literature evidence that has recently become available.

In particular, a positive opinion was given to the use of the sotrovimab antibody which demonstrated a favourable benefit/risk ratio even against the main circulating variants of SARS-CoV-2. The approval of this new antibody was also based on the authorisation procedure for temporary distribution by decree of the Ministry of Health, and this antibody is therefore to be added to the others already available (bamlanivamb/etesevimab and casirivimab/imdevimab).

Moreover, the results of the international RECOVERY clinical trial were evaluated and they showed a benefit in terms of mortality and a reduction in the risk of disease progression (recourse to mechanical ventilation or death) as for the treatment with casirivimab and imdevimab in adult patients hospitalised for COVID-19, even in conventional oxygen therapy (not at high flow rates and not in mechanical ventilation), and with negative serology for anti-Spike IgG antibodies to SARS-CoV-2. The Agency therefore decided to extend the possible use of the casirivimab/imdevimab combination in this subpopulation.

The relative determinations will be published in the Official Journal on 6 August 2021 and will be effective from the day following publication.

Finally, in view of the epidemiological scenario of the prevalence of SARS-CoV-2 variants, which has rapidly changed in recent weeks, attention is drawn to the fact that the currently available anti-SARS-CoV-2 monoclonal antibodies, although having overlapping indications for use, differ from each other, on the basis of recent literature evidence, in their ability to neutralise the different circulating variants. All anti-SARS-CoV-2 antibodies available in Italy (bamlanivamb/etesevimab, casirivimab/imdevimab and sotrovimab) maintain adequate antiviral activity against the alpha (lineage B.1.1.7) and delta (lineage B.1 .617.2), while the neutralising activity of the bamlanivamb/etesevimab combination, unlike the other available monoclonal antibodies (casirivimab/imdevimab and sotrovimab), is strongly inhibited against the beta (B.1.351) and gamma (P.1) variants. Therefore, in geographical areas where beta and gamma variants are circulating, it is suggested to use monoclonal antibodies (casirivimab/imdevimab and sotrovimab) effective against all variants or to precede the start of therapy by genotyping/sequencing.


Published on: 05 August 2021

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