Regulatory Decision Summary for Saxenda
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this submission is to seek market authorization for Saxenda as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and above with:
- an inadequate response to reduced calorie diet and increased physical activity alone, and
- a body weight above 60 kg (132 lbs), and
- an initial body mass index (BMI) corresponding to ≥30 kg/m2 for adults (obesity) by international cut-offs (see Table 1 in the Product Monograph for details).
Why was the decision issued?
The efficacy and safety of Saxenda were studied in one clinical trial that enrolled 251 adolescent patients with obesity. Patients with type 2 diabetes mellitus were excluded. Subjects received counselling on healthy nutrition and physical activity throughout the trial. The mean age of the patients was 14.5 years, the mean baseline body weight was 100.8 kg, mean Body Mass Index (BMI) was 35.6 kg/m2, and mean BMI Standard Deviation Score (BMI SDS) was 3.2. Treatment with Saxenda was initiated with 0.6 mg daily for one week and increased in weekly steps of 0.6 mg until the 3.0 mg dose of Saxenda or a maximum tolerated dose was reached. The primary efficacy endpoint in this study was change in BMI SDS at Week 56.
The efficacy of Saxenda in the target adolescent population was demonstrated. Treatment with Saxenda resulted in a clinically meaningful and statistically significant reduction in BMI SDS compared to placebo. Secondary efficacy endpoints included changes in body weight, BMI, waist circumference, and cardiometabolic parameters, and were consistent with the primary endpoint and suggestive of clinical benefit. Significant weight regain was seen after drug discontinuation.
In total, 125 adolescent patients were exposed to Saxenda for 56 weeks. A proportion of 10.4% of Saxenda patients discontinued treatment due to an adverse reaction (AR). Relevant ARs occurring at a higher rate in the Saxenda than the placebo group included nausea, vomiting, diarrhea, hypoglycemia, gastroenteritis, and dizziness. Moderate increases from baseline in resting heart rate were observed with Saxenda. No severe hypoglycemic episodes occurred in the Saxenda group. There was one death due to suicide in a Saxenda patient and one Saxenda patient had an event of pancreatitis. The frequency, type and severity of adverse reactions in the pediatric patients with obesity were consistent with that observed in the adult population. Vomiting occurred with a 2-fold higher frequency in pediatric patients compared to adults.
Overall, based on the clinical data provided and as labelled, the benefit/risk profile of Saxenda as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management is considered to be favourable in the target adolescent patient population.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.