Novo Nordisk seeks label update for Fiasp in children

Novo Nordisk has submitted label updates to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for use of Fiasp (fast-acting insulin aspart) as a new mealtime insulin for children and adolescents with type I diabetes.

Parents have reported that mealtimes are a particular stress for children and adolescents with diabetes type I, and skipping meals and snacking also pose challenges for diabetes management.

The submissions are based on the results from the onset 7 trial which investigated the efficacy and safety of the frug compared to conventional insulin aspart in children and adolescents with type I diabetes.

The trial consisted of 777 people all of whom were children or adolescents with type I diabetes, and found that the participants achieved superior control of overall blood sugar levels with Fiasp, as well as significantly lower overall post-meal blood sugar levels one hour after the meal. Both of these were compared to conventional insulin aspart, when dosed at mealtime.

“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 the Danish group.

“We believe that Fiasp can help this younger population manage their diabetes.”

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