Novo Nordisk announced it recently submitted label updates to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for Fiasp® (insulin aspart injection) 100 u/mL, seeking approval for use as a new mealtime insulin for children and adolescents with type 1 diabetes. Fiasp® is currently approved to control high blood sugar in adults with diabetes.
"Clinical experience shows that for conventional rapid-acting insulins to work best, they need to be administered ahead of the meal, which might require a lot of guesswork. Fiasp® has a faster acting profile of action, compared to conventional insulin aspart, and can be administered at the start of the meal, which can help reduce the guessing around mealtime," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The submissions are based on the results from the onset 7 trial which investigated the efficacy and safety of Fiasp® compared with conventional insulin aspart in children and adolescents with type 1 diabetes. We anticipate a response from the EMA later this year, and from the FDA in early 2020.
Fiasp® is the first fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp® is administered at the beginning of a meal or within 20 minutes after starting a meal.
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