AstraZeneca Scores Its First Global Approval For Antibody Evusheld As COVID-19 Treatment

  • The regulatory authority in Japan has approved AstraZeneca plc's AZN Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination for prevention (pre-exposure prophylaxis) and treatment of COVID-19. 
  • The decision marks the first global marketing approval for Evusheld as a treatment for COVID-19.
  • The Japanese government has agreed to purchase 300,000 units of Evusheld (150mg each of tixagevimab and cilgavimab), and AstraZeneca is working with the government and partners to make the first doses available as soon as possible.
  • Related: AstraZeneca's CEO Says There Are No COVID Regrets, Looks For Oncology Acquisitions.
  • The approvals were based on the Evusheld clinical development program, including the PROVENT Phase 3 pre-exposure prophylaxis trial, the TACKLE Phase 3 outpatient treatment trial, and Phase 1 trials.
  • In PROVENT, a 300mg intramuscular dose of Evusheld significantly reduced the risk of developing symptomatic COVID-19 by 77%.
  • An 83% relative risk reduction was shown at a six-month median follow-up analysis, with protection from the virus lasting six months.
  • Evusheld has been shown to retain in vitro neutralization activity against the main Omicron variants currently circulating globally.
  • Price Action: AZN shares are down 2.77% at $64.01 on the last check Tuesday.
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