Fast-acting insulin aspart approved for children

The European Commission has granted an extension to the indication of Fiasp (fast-acting insulin aspart). It is now approved for the treatment of diabetes in adolescents and children aged one year and above. Previously, it was licensed only for use in adults with diabetes (type 1 or type 2).

Fiasp is an ultra-fast acting mealtime insulin analogue; it is a newer formulation of insulin aspart that more closely matches the natural physiological insulin response to the rise in blood glucose occurring after meals. It contains two excipients not present in conventional insulin aspart: vitamin B3 (niacinamide) to increase speed of absorption, and the amino acid L-arginine for stability. Fiasp is absorbed into the bloodstream more rapidly than conventional insulin aspart (NovoRapid), leading to improved glycaemic control after meals. It received a marketing authorisation for use in adults in January 2017.

Fiasp is available in a pre-filled pen, cartridge or vial for subcutaneous injection. In children, it is recommended that Fiasp is administered 0–2 minutes before the start of a meal. However, in situations when there is uncertainty about food intake, it can also be administered up to 20 minutes after the start of a meal. Close monitoring of blood glucose is recommended with post-meal dosing at dinner time to avoid nocturnal hypoglycaemia.

The approval follows the results of the onset 7 trial, which studied the safety and efficacy of Fiasp compared with conventional insulin aspart in 777 children and adolescents aged 2–18 years with type 1 diabetes over a period of six months. The phase 3b trial showed that treatment with Fiasp was associated with superior glycaemic control (as measured by HbA1c) and lower post-prandial blood glucose one hour after a meal compared with conventional insulin aspart, when the drugs were dosed at mealtime as part of a basal-bolus regimen in combination with basal insulin degludec. Fiasp and conventional insulin aspart showed similar safety profiles, including risk of severe hypoglycaemia.



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