- 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.
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