Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents

PLAINSBORO, NJ, USA I March 1, 2019 I Novo Nordisk today announced that 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.

Managing diabetes around mealtimes can be hard1, with parents of young children with type 1 diabetes reporting that this was one of the most problematic areas2. Skipping meals and snacking as an adolescent also pose challenges for diabetes management3.

"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 diabetes4. We anticipate a response from the EMA later this year, and from the FDA in early 2020.

About Fiasp®
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.5

About the study4
The onset 7 trial (777 people randomised) was a 26-week, phase 3b, partially double-blind, basal-bolus, treat-to-target trial, evaluating the efficacy and safety of Fiasp®, dosed at mealtime (0-2 minutes before starting the meal) or 20 minutes after the start of the meal, compared with conventional insulin aspart dosed at mealtime, in children and adolescents with type 1 diabetes. All treatment arms involved a multiple daily injection routine (basal-bolus) using insulin degludec as the basal insulin.

Indications and Usage

What is Fiasp® (insulin aspart injection) 100 U/mL?

  • Fiasp® is a man-made insulin used to control high blood sugar in adults with diabetes mellitus. It is not known if Fiasp® is safe and effective in children.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 43,200 people in 80 countries and markets its products in more than 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit, Facebook, Twitter, LinkedIn, YouTube.


   Streisand R and Monaghan M. Young children with type 1 diabetes: Challenges, research, and future directions. Current Diabetes Reports 2014; 14(9): 520: doi: 10.1007/s11892-014-0520-2.

   Wysocki T, et al. Adjustment to diabetes mellitus in preschoolers and their mothers. Diabetes Care 1989; 12(8):524-29.

   Øverby NC, et al. Sweets, snacking habits, and skipping meals in children and adolescents on intensive insulin treatment. Pediatric diabetes 2008; 9:393-400.

   Bode B, et al. Efficacy and safety of fast-acting insulin aspart compared with insulin aspart, both in combination with insulin degludec, in children and adolescents with type 1 diabetes: the onset 7 trial. Poster presentation at the 44th Annual Conference of ISPAD. 11-14 October 2018; Hyderabad, India.

   Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2017.

Fiasp® is a registered trademark of Novo Nordisk A/S.

SOURCE: Novo Nordisk

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