Covid, Aifa: new rules for monoclonal use based on variants

Covid, Aifa: new rules for monoclonal use based on variants

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Covid, Aifa: new rules for monoclonal use based on variants

The methods of use of anti-Covid monoclonal antibodies are changing. This was announced by the Italian drug agency Aifa, informing that it had given “a positive opinion on the use of the sotrovimab antibody, which has shown a favorable benefit / risk ratio even against the main circulating variants of Sars-CoV-2”. Furthermore – according to the results of the international study Recovery, which showed “a benefit in terms of mortality and reduction in the risk of disease progression of treatment with casirivimab and imdevimab in adult patients hospitalized for Covid-19, even on conventional oxygen therapy (not at high flows and not in mechanical ventilation) and with negative serology for Sars-CoV-2 anti-Spike IgG antibodies “- the national regulatory body has decided to” extend the possible use of the casirivimab / imdevimab combination in this subpopulation ” .

“In consideration of the epidemiological scenario of prevalence of the variants of Sars-CoV-2, rapidly mutated in the last few weeks”, the Aifa warns that “the monoclonal antibodies against Sars-CoV-2 currently available, despite having overlapping indications for use, they differ from each other, on the basis of recent literature evidence, for their ability to neutralize the different circulating variants “. In particular, “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 neutralizing 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 the geographical areas where there is a circulation of the Beta and Gamma variants”, the agency suggests to “use the monoclonal antibodies casirivimab / imdevimab and sotrovimab, effective against all variants, or to precede the initiation of therapy by genotyping / sequencing “.

Also for the approval of sotrovimab, the AIFA points out, “the procedure of authorization for temporary distribution by decree of the Minister of Health was used, and this antibody is therefore added to the others already available (bamlanivamb / etesevimab and casirivimab / imdevimab) .

The determinations on the green light to sotrovimab and on the extension of use of casirivimab / imdevimab “will be published in the Official Gazette of August 6, 2021 – concludes the agency – and will be effective from the day following publication”.

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