AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe Covid-19.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the TACKLE phase III Covid-19 treatment trial which showed one intramuscular (IM) dose of Evusheld provided clinically and statistically significant protection against progression to severe Covid-19 or death from any cause compared to placebo. Evusheld treatment earlier in the disease course led to more favourable outcomes. TACKLE was conducted in non-hospitalised adults with mild-to-moderate Covid-19 who were symptomatic for seven days or less. 90% of trial participants were at high risk of progression to severe Covid-19 due to co-morbidities or age. Evusheld was generally well tolerated in the trial.
Michel Goldman, M.D., Ph.D., Professor, Institute for Interdisciplinary Innovation in Healthcare, Universit
