Available in Italy for several months for emergency use, now the combination of long-acting antibodies tixagevimab and cilgavimab has been approved in the European Union and is added to the list of drugs indicated for the treatment of Covid19. In particular, the combo is used to treat adults and adolescents (from 12 years of age and weighing at least 40 kg) who have developed the disease but do not need supplemental oxygen, and who are at high risk. to progress towards a severe form of Covid19.
Anti-Covid prophylaxis, it is necessary to accelerate the administration
by Sara Carmignani
The approval by the European Commission is based on the results of the phase III TACKLE study which showed that an intramuscular dose of tixagevimab and cilgavimab can protect against progression to severe Covid19 or death from any cause in a statistically superior manner. compared to placebo. The study, which was conducted on non-hospitalized adults with mild-to-moderate, symptomatic Covid19 for seven days or less, also indicates that the drugs protect more when given promptly. Ninety percent of the study participants were at high risk of progression to a severe form of the disease due to the presence of other diseases or due to advanced age.
“Many people, including those who are immunocompromised, older adults and those with comorbidities, are at high risk of serious illness, hospitalization and death from infection,” explained Stefano Vella, adjunct professor of Global Health at the Catholic University of Rome. “The combination of thixagevimab and cilgavimab antibodies, administered comfortably intramuscularly, already available in Italy, pursuant to law 648/96, for emergency therapeutic use thanks to the authorization of the Technical Scientific Commission of AIFA based on both results of clinical studies already published and on the interim analysis (on about 450 patients) of an ongoing multicenter study in Italy (Mantico-2), is now a new treatment option for COVID-19, extremely necessary for these vulnerable populations ” .
Action on variants
The data obtained in the laboratory indicate that the combination of antibodies is able to neutralize Omicron BA.5, the variant of SARS-CoV-2 dominant in Europe today. The real-life data demonstrates that tixagevimab and cilgavimab are also effective against the other variants: significantly lower rates of symptomatic Covid19 and / or hospitalization / death due to immunocompromised patients who received the combination of antibodies were recorded. patients compared to the control arms. This includes real-world evidence collected while Omicron BA.5, BA.4, BA.2, BA.1 and BA.1.1 were in circulation.
Covid, monoclonal preventive therapy is also effective against Omicron variants
by Dario Rubino
The antibody combination had already obtained EU marketing authorization earlier this year for pre-exposure prophylaxis (prevention) of COVID-19 in a large population of immunocompromised adults and adolescents.