Regulatory Decision Summary for Wegovy

The purpose of this Supplement New Drug Submission (SNDS) was to seek expansion of indication, pursuant to section C.08.004 of the Food and Drugs Regulations, for Wegovy, submitted by Novo Nordisk Canada Inc. for the use of Wegovy (semaglutide injection) for weight management in adolescent (aged 12 to <18 years) patients with obesity.

The authorized indication (adults) and proposed indication (adolescents) were:

Wegovy (semaglutide injection) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in:

• Adult patients with an initial body mass index (BMI) of

  • 30 kg/m² or greater (obesity), or

  • 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.

• Pediatric patients aged 12 to less than 18 years with an initial BMI at the

  • 95^th percentile or greater for age and sex (obesity), or

  • 85^th percentile or greater for age and sex (overweight) in the presence of at least one weight-related comorbidity.

Upon review, the approved indication was:

Wegovy (semaglutide injection) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in:

• Adult patients with an initial body mass index (BMI) of

  • 30 kg/m² or greater (obesity), or

  • 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.

• Pediatric patients aged 12 to less than 18 years:

  • with an initial BMI at the 95^th percentile or greater for age and sex (obesity), and

  • a body weight above 60 kg (132 lbs.), and

  • an inadequate response to reduced calorie diet and physical activity alone.

• Authorization was based on 1 Phase 3 double-blind randomized controlled trial in adolescents aged 12 to <18 years who had obesity, as defined as a body mass index (BMI) equal to or greater than the 95^th percentile for age and sex according to standard growth charts. Patients were randomized to receive Wegovy at a maintenance dose of 2.4 mg by subcutaneous injection once-weekly (n = 134 patients) or to a matched placebo (n = 67) for up to 68 weeks, including a dose escalation period.

• Superiority of Wegovy over placebo at Week 68 was demonstrated for the primary endpoint of percent change from baseline BMI and for the confirmatory secondary endpoint of proportion of patients achieving a reduction of at least 5% in body weight. At Week 68, the treatment difference in percent change from baseline BMI was -16.75% for Wegovy-treated patients compared to placebo. There were 72.5% of Wegovy and 17.7% of placebo patients that achieved at least 5% body weight loss by Week 68.

• The most common adverse events in adolescent patients treated with Wegovy were nausea (42.1%), vomiting (36.1%), and diarrhea (21.8%). The safety profile in adolescent patients was consistent with the established profile for Wegovy in adults.

• The recommended maintenance dose of the drug is 2.4 mg once-weekly, following a 16-week dose escalation protocol intended to decrease risk of gastrointestinal disorders. View the product monograph for details.

• Based on the data in the submission package, the overall benefit-risk profile for Wegovy for the indication of weight management in adolescent (aged 12 to <18 years) patients with obesity is positive.

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