PLAINSBORO, N.J., March 1, 2019 /PRNewswire/ -- Novo Nordisk today announced that it recently submitted label updates tothe 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®
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 study4The 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?
Selected Important Safety Information for Fiasp®
Do not share your Fiasp® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Who should not take Fiasp®?Do not take Fiasp® if:
Before taking Fiasp® tell your health care provider about all your medical conditions including, if you:
Talk to your health care provider about low blood sugar and how to manage it.
How should I take Fiasp®?
What should I avoid while taking Fiasp®?
What are the possible side effects of Fiasp®?Serious side effects can lead to death, including:
Low blood sugar (hypoglycemia). Some signs and symptoms include:
Your insulin dose may need to change because of:
Common side effects of Fiasp® may include:
Please see Prescribing Information for Fiasp at http://www.novo-pi.com/fiasp.pdf
About Novo NordiskNovo 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 novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Fiasp® is a registered trademark of Novo Nordisk A/S.Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2019 Novo Nordisk All rights reserved. US19FSP00064 February 2019
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SOURCE Novo Nordisk
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