Regulatory Decision Summary for Tresiba
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 Supplemental New Drug Submission (SNDS) is to expand the market authorization of Tresiba (insulin degludec) to include the treatment of pediatric patients (age 1 year to less than 18 years) with type 1 diabetes mellitus (T1DM).
Upon review, the indication for treatment of pediatric patients (age 2 years to less than 18 years) with type 1 diabetes mellitus (T1DM) is recommended.
Why was the decision issued?
Tresiba (insulin degludec) received market authorization for adults with diabetes mellitus (type 1 and 2) to improve glycemic control in August 2017.
Trial 3561, an open-labelled, randomized, treat-to-target study, compared the efficacy and safety of Tresiba + insulin aspart (IAsp) in pediatric patients (age 1 year to less than 18 years) with type 1 diabetes mellitus (T1DM) to the efficacy and safety of Levemir (insulin detemir) + IAsp following 26 weeks of treatment.
The results showed that the efficacy (improved glycemic control as measured by glycosylated hemoglobin [HA1c]) of Tresiba + IAsp was non-inferior to the efficacy of Levemir + IAsp based on a non-inferior margin of 0.4%.
Tresiba is administered once daily compared to other basal insulins (e.g. Levemir or NPH) which may require twice daily injections.
Hypoglycemia remains the most common adverse effect of insulin products and all insulin products are labelled for this risk. In Study 3561, the rates of hypoglycemia appeared comparable between the Tresiba and Levemir treatment arms.
Pediatric patients with T1DM are prone to ketoacidosis. The rates of hyperglycemic episodes and nocturnal hyperglycemic episodes appeared comparable between the two arms while the rate of hyperglycemic episodes with ketosis appeared lower in the Tresiba group than the Levemir group.
The clinical data on pediatric patients (age 1-2 years) were very limited: 2 subjects per treatment group. In addition, the rates of severe hypoglycemia (including severe asymptomatic hypoglycemia) and hyperglycemia in this age group were much higher than the rates in the other age groups. Given these observations, the benefit/risk profiles of Tresiba in this age group appeared to be unfavourable.
Upon review of the submitted data, the benefit/risk profile of Tresiba for pediatric subjects (age 2 years to less than 18 years) was determined to be comparable to that of Levemir which has already been authorized for pediatric patients (age 2 years and over) with T1DM.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.