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01 Mar 2019 13:00 CET

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

Bagsværd, Denmark, 1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the European Medicines Agency (EMA) and the US Food and Drug Administration (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 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. "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 diabetes4. We anticipate a response from the EMA later this year, and from the FDA in early 2020.

About Fiasp®

Fiasp® is the only approved, new-generation, ultra-fast acting5-7 mealtime insulin injection. Fiasp® is insulin aspart in an innovative formulation, in which two excipients have been added: Vitamin B3 (niacinamide) to increase the speed of absorption, and a naturally occurring amino acid (L-Arginine) for stability8. The result is a mealtime insulin that more closely approaches the natural physiological insulin response of a person without diabetes after a meal, compared with conventional insulin aspart8.

Fiasp® is currently indicated for the treatment of type 1 and type 2 diabetes in adults only.

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) and 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. 

The study showed that children and adolescents with type 1 diabetes achieved superior control of overall blood sugar levels (HbA1c) with Fiasp®, as well as significantly lower overall post-meal blood sugar levels (one hour after the meal), compared to conventional insulin aspart, when both treatments were dosed at mealtime. 

In addition, the results in those that injected Fiasp® 20 minutes after the start of the meal showed that Fiasp® provided similar control of overall blood sugar levels (non-inferior), compared to conventional insulin aspart dosed at mealtime.

Further information

Media:    
Mette Kruse Danielsen +45 3079 3883 mkd@novonordisk.com
     
Investors:    
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Valdemar Borum Svarrer +45 3079 0301 jvls@novonordisk.com
Ann Søndermølle Rendbæk +45 3075 2253 arnd@novonordisk.com

  

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References

  1. 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.
  2. Wysocki T, et al. Adjustment to diabetes mellitus in preschoolers and their mothers. Diabetes Care 1989; 12(8):524-29.
  3. Øverby NC, et al. Sweets, snacking habits, and skipping meals in children and adolescents on intensive insulin treatment. Pediatric diabetes 2008; 9:393-400.
  4. 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.
  5. Cengiz E, et al. Moving toward the ideal insulin for insulin pumps. Expert Review of Medical Devices 2016; 13(1):57-69.
  6. Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the art. Journal of Diabetes Science and Technology 2012; 6:728-42.
  7. Russell-Jones D, et al. Fast-acting insulin aspart improves glycemic control in basal-bolus treatment for type 1 diabetes: results of a 26-week multicenter, active-controlled, treat-to-target, randomized, parallel-group trial (onset 1). Diabetes Care 2017; 40(7):943-50.
  8. Heise T, et al. A pooled analysis of clinical pharmacology trials investigating the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clinical Pharmacokinetics 2017; 56(5):551-9.