Regulatory Decision Summary for Evusheld

The efficacy and safety of Evusheld for the treatment of mild to moderate COVID-19 in adult and adolescent patients were evaluated in study TACKLE, an ongoing Phase III, randomized, double-blind, placebocontrolled clinical trial. Most participants were documented to be at high risk of progression to severe COVID-19. Patients received Evusheld 600 mg (N=413) or placebo (N=421) by intramuscular injection.

The primary efficacy endpoint was a composite of either severe COVID-19 or death from any cause by Day 29, in subjects who received treatment within 7 days from symptom onset and were not hospitalized at baseline.

The efficacy of Evusheld in the target patient population was demonstrated. The results of the primary endpoint demonstrated a statistically significant reduction in severe COVID-19 or death from any cause compared to placebo. The results of the primary composite endpoint were driven by the incidence of severe COVID-19.

A total of 452 non-hospitalized adult patients with mild to moderate COVID-19 received 600 mg of Evusheld (300 mg of tixagevimab and 300 mg of cilgavimab). During a median follow-up of 170 days, adverse events were reported in 174 (38.5%) subjects receiving Evusheld and 196 (43.5%) receiving placebo. The most frequently reported adverse reaction was injection site reaction (2.4%). The overall safety profile in patients who received 600 mg IM Evusheld for the treatment indication was generally similar to that reported in participants who received 300 mg Evusheld for the prevention indication.

The RMP was reviewed and considered acceptable. The RMP identified appropriate monitoring (pharmacovigilance) activities and risk minimization measures based on safety profile of this product. This included providing information in the product monograph and identifying special populations where more data is needed. In addition to regulatory requirements for post-market monitoring, periodic benefit-risk evaluation reports will be provided on a regular basis to Health Canada for review. Results related to safety and effectiveness from ongoing and planned studies will be submitted as they become available.

Overall, the benefits of Evusheld outweighs its risks in adult and adolescent patients with moderate to severe COVID-19. The benefit/risk profile of Evusheld is deemed favourable in the target patient population.

For further details about Evusheld (tixagevimab and cilgavimab), please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.