Health Canada approves Evusheld for pre-exposure prophylaxis of COVID 19 in Canada. AstraZeneca
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination has received a Notice of Compliance from Health Canada for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (?12 years of age weighing at least 40kg), who have not had a known recent exposure to an individual infected with SARS-CoV-2 and who are immune-compromised and unlikely to mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended.
Pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
The approval follows AstraZeneca’s announcement in February 2022 that it had signed an agreement with the Government of Canada for the supply of Evusheld, which is now in Canada. The approval by Health Canada was based on results from the Evusheld clinical development program, including data from the PROVENT Phase III pre-exposure prophylaxis trial which showed a 77% reduction in the risk of developing symptomatic COVID-19 compared to placebo at the primary analysis and an 83% reduction at a six-month median analysis, with protection from the virus lasting at least six months. Evusheld was generally well-tolerated in the trial..
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