Regulatory Decision Summary for Wegovy

The purpose of this submission was for Wegovy for an indication of reduction of risk of non-fatal myocardial infarction (MI) in adults with body mass index (BMI) ≥27 and established cardiovascular (CV) disease.

Wegovy was previously authorized for the indication of weight management in patients with obesity or overweight with comorbidities.

Authorization was based on 1 international, multi-centre, randomized, double-blind, placebo-controlled trial (SELECT). Patients (n = 17,604) with BMI ≥27 and established cardiovascular (CV) disease received either Wegovy (n = 8,803) or placebo (n = 8,801) for a mean trial duration of approximately 40 months.

The primary efficacy endpoint was time to first confirmed major adverse cardiac event (MACE), a composite endpoint consisting of CV death, non-fatal stroke, and non-fatal myocardial infarction (MI). A benefit of Wegovy over placebo was shown for this endpoint; the benefit was primarily driven by the component of non-fatal MI.

In the SELECT study, safety data collection focused primarily on serious adverse events and previously-identified safety concerns for semaglutide. Adverse reactions reported more commonly for Wegovy compared to placebo included nausea, vomiting, diarrhea, headaches, and fatigue. Other events of interest included dizziness, gall bladder disorders, taste disturbances, abnormal skin sensations, and certain (femur, pelvic and hip) fractures. Overall, the safety profile of semaglutide in the SELECT study was generally similar to that previously established for Wegovy.

The recommended dose of the drug includes a 16-week dose escalation phase to the target maintenance dose of 2.4 mg once-weekly. View the product monograph (PM) for details.

An updated Risk Management Plan (RMP) for Wegovy was reviewed by Health Canada and considered acceptable.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-risk profile for Wegovy in overweight or obese adults with established CV disease for the indication of reduction of risk of non-fatal MI is considered positive. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Wegovy, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.