AstraZeneca (LON:AZN) has announced that its long-acting antibody combination Evusheld (tixagevimab and cilgavimab) has received marketing authorization in the European Union.
Formerly known as AZD7442, Evusheld is indicated for treating individuals 12 and older infected with SARS-CoV-2 who are at risk for severe COVID-19. The indication is limited to those weighing at least 40 kg who do not need supplemental oxygen.
European regulators based their recommendations on data from the placebo-controlled Phase 3 TACKLE COVID-19 study that demonstrated a single intramuscular (IM) dose of Evusheld.
Evusheld thus differs from other COVID-19 antibodies that require an infusion.
The placebo-controlled TACKLE study found that Evusheld provided clinically and statistically significant protection against severe COVID-19 or death from any cause compared.
Outcomes were best for individuals who received Evusheld therapy at an early stage of disease pr…