Regulatory Decision Summary for Fiasp

The efficacy and safety of Fiasp were assessed in three randomized, active-controlled studies, conducted in both patients with type 1 diabetes and type 2 diabetes. In both type 1 and type 2 diabetes clinical studies, Fiasp demonstrated a reduction from baseline of HbA1c. The treatment effect of Fiasp on HbA1c was similar to the active control, NovoRapid (marketed insulin in Canada with the same active ingredient as Fiasp).

Fiasp is supplied in 10 mL vials, 3 mL Penfill cartridges, and 3 mL FlexTouch prefilled pens for subcutaneous injection. Fiasp should generally be used in a regimen with intermediate- or long-acting insulin (plus metformin for type 2 diabetes, as recommended). The dose of Fiasp is based on the patients insulin needs to control hyperglycemia.

Overall, the safety profile of Fiasp has been found to be similar to NovoRapid with respect to adverse events of interest (for example, hypoglycemia, allergic reactions, lipodystrophy, etc.). However, likely due to a faster absorption of Fiasp, more frequent hypoglycemic episodes during the first 1-2 hours following mealtime injection was observed in Fiasp-treated patients compared to NovoRapid-treated patients.

Taking into account the above, the benefit/risk ratio is considered favorable. However, in order to ensure that this benefit continues to outweigh risk after authorization, Health Canada has required a Risk Management Plan and several standard, post-approval activities.