Long-Acting COVID-19 Antibody Approved in Canada

AstraZeneca announced yesterday that Evusheld™ had received a Notice of Compliance from Health Canada for treating mild to moderate COVID-19 in adults and certain adolescents.

This approval follows AstraZeneca's announcement in April 2022 that Evusheld, a long-acting antibody combination, 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, in a press release on October 18, 2022.

 "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, ensuring 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 a reduced risk of severe COVID-19 or death in high-risk patients.

In the TACKLE study, one intramuscular dose of Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to a placebo. 

Evusheld treatment earlier in the disease course led to more favorable outcomes.

Evusheld has been shown to retain in vitro neutralization activity against the main Omicron variants currently circulating globally, including BA.5.

Evusheld is the only long-acting antibody combination with positive Phase III data in preventing and treating COVID-19.

Additional SARS-CoV-2 antibody prevention and treatment news is posted at PrecisionVaccinations.com/Antibodies.