Fiasp approved in Europe for the management of diabetes in adolescents and children aged one year and above

Bagsværd, Denmark, 22 August 2019 - Novo Nordisk today announced that the European Commission has granted an extension of the indication for Fiasp® (fast-acting insulin aspart), approving it for the treatment of diabetes in adolescents and children (aged one year and above). This complements the previous indication, which covered adults only.

"We are very pleased with the decision of the European Commission to expand the indication of Fiasp®, making it available within this younger population," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "With this expanded indication, we hope that adolescents and children who are at least one year old will find in Fiasp® a good option in the management of their diabetes."

For this paediatric population, it is recommended that Fiasp® is administered prior to the meal (0-2 minutes before the start of the meal). However, Fiasp® can also be administered up to 20 minutes after the start of a meal (post-meal dosing) in situations when there is uncertainty about the meal intake. Close monitoring of blood sugar levels is advised when dosing Fiasp® post-meal at dinner time to avoid nocturnal hypoglycaemia (low blood sugar levels)1.

About Fiasp®

Fiasp® is the only approved, new-generation, ultra-fast acting2-4 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 stability, when compared to the conventional formulation of insulin aspart5. The result is a mealtime insulin that more closely mimics the natural physiological insulin response of person without diabetes after a meal, compared with conventional insulin aspart5

Fiasp® is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged one year and above.1

Media:
Mette Kruse Danielsen +45 4442 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. Fiasp® EMA Summary of Product Characteristics. Bagsværd, Denmark: Novo Nordisk A/S. Last updated: August 2019.
  2. Cengiz E, et al. Moving toward the ideal insulin for insulin pumps. Expert Review of Medical Devices 2016; 13(1):57-69.
  3. Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the art. Journal of Diabetes Science and Technology 2012; 6:728-42.
  4. 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.
  5. 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.

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