Label updates submitted for approval at FDA and EMA for FIAsp for children and adolescents with type 1 diabetes

Novo Nordisk announced that it has submitted label updates to the European Medicines Agency (EMA) and the FDA for Fiasp (fast-acting insulin aspart), seeking approval for use as a new mealtime insulin for children and adolescents with type 1 diabetes.

Managing diabetes around mealtimes can be hard with parents of young children with type 1 diabetes reporting that this was one of the most problematic areas . Skipping meals and snacking as an adolescent also pose challenges for diabetes management. "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. "We believe that Fiasp can help this younger population manage their diabetes."

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.