Fiasp contains the active substance insulin aspart, a rapid-acting insulin.
Diabetes is a disease in which blood glucose is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes). The replacement insulin in Fiasp acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. This controls the level of blood glucose and reduces the symptoms and complications of diabetes. Insulin aspart enters the bloodstream faster than human insulin after injection and therefore works more quickly.
A clinically relevant benefit in lowering blood glucose has been shown in studies with Fiasp.
Compared with the already authorised insulin aspart medicine NovoRapid, the lowering of blood glucose develops earlier in adults given Fiasp, although the total extent of the lowering effect is similar. However, it is unclear whether this changes the risk of diabetic complications. The overall rate and severity of side effects was comparable with NovoRapid, although hypoglycaemia occurred more often in the first 2 hours after a dose of Fiasp. The benefits of Fiasp were also shown in children. Although Fiasp was not studied in children below 2 years of age, it is also expected to have a beneficial effect in younger children. The slightly higher risk of hypoglycaemia at night in children treated with Fiasp is addressed in the product information and is considered manageable.
The European Medicines Agency therefore decided that Fiasp’s benefits outweigh the identified risks and it can be authorised for use in the EU.