Regulatory Decision Summary for Fiasp
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
After evaluation of the submitted data package for an expanded indication, Health Canada authorized Fiasp (insulin aspart) for the treatment of Diabetes Mellitus in pediatric patients aged > 2 who are diagnosed with diabetes mellitus and to permit the use of Fiasp in continuous subcutaneous insulin infusion (CSII) in pump systems, which are currently licenced in Canada.
Why was the decision issued?
Pediatric indication:
Study NN1218-3854 sought to compare efficacy and safety of Fiasp versus mealtime Novorapid in combination with insulin degludec once daily in a basal-bolus regimen in subjects with type 1 diabetes mellitus (T1DM) aged 2 years to less that 18 years of age. The results demonstrated that Fiasp was non-inferior to Novorapid at maintaining glycemic control, particularly when used at mealtime, and when necessary, up to 20 minutes post meal.
The totality of currently available safety and efficacy data in pediatric T1DM and adult type 2 diabetes mellitus (T2DM), post-market safety data and long-term clinical experience with insulins of the same drug class support its use in pediatric diabetes mellitus.
Fiasp exhibited a safety profile that was consistent with other fast-acting insulins in that hypoglycemic episodes are common, especially overnight. An appropriate risk mitigation strategy for all insulins, particularly short acting ones like Fiasp is increased vigilance with blood glucose monitoring (particularly overnight), appropriate insulin storage, administration and careful individual dose titration to avoid hypo or hyperglycemic events; these are labelled appropriately in the PM.
Overall, the benefit/risk profile support the use of Fiasp for the sought indication for pediatric diabetes mellitus aged 2 to 18 years.
Pump indication:
Study NN1218-3854 sought to compare the effect and safety of continuous subcutaneous insulin infusion (CSII) treatment using Fiasp and CSII treatment with Novorapid in adult patients with T1DM. The results demonstrated that Fiasp met the non-inferior efficacy criteria, indicating that the benefit of use of Fiasp in the CSII setting is appropriate.
Fiasp exhibited a safety profile that was consistent with other fast-acting insulin in that hypoglycemic episodes are common, especially overnight. Infusion site reactions were reported in some patients. A large proportion of adverse events with insulin pumps are attributable to human factors and/or user error, indicating the importance of education.
Overall the benefit/risk profile supports the use of Fiasp for CSII use. The PM states that patients and health professionals should refer to the insulin infusion pump manufacturers user manual; this includes a list of insulins that can be used and specifies appropriate age ranges for use.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.