AstraZeneca's Evusheld Demonstrates 83% Reduction in Symptomatic COVID-19 Risk with Six-Month Protection in High-Risk Populations

Compiled by Fan Dongdong

Recently, AstraZeneca stated that in a late-stage pre-exposure prophylaxis trial, compared with placebo, the use of its long-acting antibody cocktail therapy Evusheld (tixagevimab and cilgavimab) reduced the risk of symptomatic COVID-19 infection by 83% after six months.

The result is consistent with the main analysis data released last summer. At that time, AstraZeneca stated that compared with the placebo, this therapy could reduce the risk of symptomatic infection by 77%. Over a period of six months, no severe disease or COVID-19-related deaths occurred among patients who received Evusheld treatment. AstraZeneca stated that in contrast, there were five severe cases in the placebo group, including two related deaths.

In the Provent Phase III trial, over 75% of participants were enrolled due to their risk of developing moderate to severe illness from COVID-19. The study population included immunocompromised individuals and those with an insufficient response to existing vaccines. AstraZeneca stated that the therapy was well-tolerated, with no safety issues identified during the interim or six-month analysis.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said in a press release that the trial data published on Wednesday in the New England Journal of Medicine further substantiates the clinical evidence for using Evusheld to help prevent symptomatic and severe COVID-19, particularly for those who cannot mount an adequate antibody response to vaccines and need additional protection.

In December last year, Evusheld received emergency approval from the U.S. FDA for the prevention of COVID-19 infection before exposure to the virus. Specifically, the U.S. FDA authorized Evusheld for individuals with moderately to severely compromised immune systems. Additionally, individuals who have adverse reactions to COVID-19 vaccines are also eligible to receive Evusheld treatment.

Previously, the long-acting antibody combination Evusheld has been approved for marketing in the European Union for pre-exposure prophylaxis of COVID-19 in a broad population of adults and adolescents (12 years and older weighing 40 kg and above), and received a conditional marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for pre-exposure prophylaxis of COVID-19.

AstraZeneca had predicted that sales of its COVID vaccine would decline in 2022, but part of the revenue loss would be offset by Evusheld. As of February, the company had secured an initial order of 700,000 doses across the United States, and subsequently added another 1 million doses to the U.S. market. AstraZeneca is currently seeking emergency use authorization or marketing approval for Evusheld globally for both prevention and treatment of COVID.

Reference Source: AstraZeneca's Evusheld Offers At Least 6 Months of COVID Protection in High-Risk Patients, Study Finds