AstraZeneca's Evusheld™ (tixagevimab and cilgavimab), a long-acting antibody combination has received a Notice of Compliance from Health Canada for the treatment of mild to moderate COVID-19 in adults and adolescents (≥12 years of age weighing at least 40 kg). This approval follows AstraZeneca's announcement in April that Evusheld had been approved as a preventative treatment for COVID-19 and is already available across Canada.
"Certain Canadians continue to be vulnerable to poor outcomes from COVID-19 and having a new treatment option in our arsenal, particularly one that is given as a single dose, is especially welcome news as we move into the winter months when we expect case counts to rise," said Dr. Zain Chagla, Associate Professor, Medicine, Faculty of Health Sciences, McMaster University. "Studies show long-acting antibodies can play an effective role in both treatment and prevention of COVID-19. Evusheld has already made an impact preventing infection in vulnerable populations, such as the immune-compromised, and now has the potential to play an important role in COVID-19 treatment, making sure that high risk patients have even more access to therapeutic options."
The approval by Health Canada was based on results from the TACKLE Phase III treatment trial, which demonstrated reduced risk of severe COVID-19 or death in high-risk patients.
"Today's approval marks an important step in our ongoing journey to reduce the impact of COVID-19 on the lives of Canadians," said Kiersten Combs, President of AstraZeneca Canada. "Evusheld is now the only long-acting antibody combination approved for both prevention and treatment of COVID-19 in Canada, allowing us to help protect even more people who are immune-compromised and remain most vulnerable to this devastating disease."
In TACKLE, one intramuscular (IM) dose of Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo. Evusheld treatment earlier in the disease course led to more favorable outcomes. TACKLE was conducted in non-hospitalized adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less. 90% of trial participants were at high risk of progression to severe COVID-19 due to co-morbidities or age. Evusheld was generally well tolerated in the trial. The recommended dose of Evusheld for treatment in Canada is 300mg of tixagevimab and 300mg of cilgavimab, administered as two separate, sequential IM injections.
Evusheld has been shown to retain in vitro neutralization activity against the main Omicron variants currently circulating globally, including BA.5 and BA.2.
Evusheld is the only long-acting antibody combination with positive Phase III data in the prevention and treatment of COVID-19.
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