AstraZeneca's COVID-19 Antibody Treatment Scores Approval In Europe

The European Commission has approved AstraZeneca plc's AZN Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination as COVID-19 treatment in adults and adolescents.
The approval comes for COVID-19 patients who do not require supplemental oxygen and are at increased risk of progressing to severe COVID‑19.
The approval was based on results from the TACKLE Phase 3 trial, which showed that one intramuscular dose of Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo.
Related: AstraZeneca Scores Its First Global Approval For Antibody Evusheld As COVID-19 Treatment.
Evusheld treatment earlier in the disease course led to more favorable outcomes and was generally well tolerated in the trial.
The recommended dose of Evusheld for treatment in Europe is 300mg of tixagevimab and 300mg of cilgavimab, administered as two separate, sequential IM injections.
Evusheld has been shown to retain in vitro neutralization of omicron BA.5.
Evusheld was approved in Europe for pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents earlier this year.
Price Action: AZN shares are down 1.35% at $57.21 on the last check Tuesday.