Antibody authorized for the early treatment of COVID-19 in subjects at risk of progression
The Technical Scientific Commission (CTS) of AIFA has authorized the use of the Evusheld monoclonal antibody (tixagevimab and cilgavimab) in the early treatment of subjects infected with SARS-CoV-2 at risk of a severe form of COVID-19. Until now, the medicine was only available for pre-exposure prophylaxis in high-risk individuals. With this extension of indication, AIFA makes available an intramuscular therapeutic option for subjects in whom the prescription of antiviral drugs and authorized monoclonal antibodies is considered inappropriate from a clinical and / or epidemiological point of view (in relation to the circulation of viral variants).
AIFA's decision to authorize Evusheld for the treatment of patients with COVID-19 anticipates the EMA's assessment that will be completed in September 2022, and is based both on the results of the clinical studies already published and on the interim analysis (out of approximately 450 patients) of an ongoing multicenter study in Italy (Mantico-2, coordinated by Prof. Tacconelli, University of Verona), funded by the Agency with the aim of comparing three different alternatives (Evusheld, Paxlovid and Xevudy) in early treatment of patients with COVID-19.
Evusheld was therefore included in the list of drugs payable by the NHS pursuant to law 648/96. For the prescription operating procedures, please refer to the AIFA institutional website at https://www.aifa.gov.it/registri-e-piani-terapeutici1.
The determination is published today in the Official Gazette and will take effect from today, 3 August 2022.