Novo Nordisk recently submitted label updates to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for Fiasp® (insulin aspart injection) 100 u/mL.
The Danish company is seeking approval for use of the drug as new mealtime insulin for children and adolescents with Type 1 diabetes. Fiasp® is currently approved to control high blood sugar in adults with 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,” said Mads Krogsgaard Thomsen, executive vice president, and chief science officer of Novo Nordisk. “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.”
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.
The company anticipates a response from the EMA later this year, and from the FDA in early 2020. View the full press release here.
Source:
- Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents. (2019, March 1). PR Newswire. Retrieved: https://prnmedia.prnewswire.com/news-releases/novo-nordisk-files-for-a-label-update-for-fiasp-to-the-ema-and-the-fda-seeking-approval-for-use-in-children-and-adolescents-300804894.html