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

News provided by

Mar 01, 2019, 07:00 ET

PLAINSBORO, N.J., March 1, 2019 /PRNewswire/ -- 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 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?

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.

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:

your blood sugar is too low (hypoglycemia) or you are allergic to any of its ingredients.

Before taking Fiasp^® tell your health care provider about all your medical conditions including, if you:

have kidney or liver problems
are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Fiasp^® passes into your breast milk.
are taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about low blood sugar and how to manage it.

How should I take Fiasp^®?

Read the Instructions for Use and take Fiasp^® exactly as your health care provider tells you to.
Fiasp^® starts acting fast. You should take your dose of Fiasp^® at the beginning of the meal or within 20 minutes after starting a meal.
Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
If you miss a dose of Fiasp^® monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.

What should I avoid while taking Fiasp^®?

Do not drive or operate heavy machinery, until you know how Fiasp^®affects you.
Do not drink alcohol or use medicines that contain alcohol.

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:

anxiety, irritability, mood changes, dizziness or light-headedness, sweating, confusion, and headache.

Your insulin dose may need to change because of:

weight gain or loss, increased stress, illness, or change in diet or level of physical activity.
low potassium in your blood (hypokalemia).
serious allergic reactions (whole body reactions). Get emergency medical help right away if you have a rash over your whole body; trouble breathing; a fast heartbeat; swelling of your face, tongue or throat; sweating; extreme drowsiness; dizziness, or confusion.
heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Fiasp^® may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Fiasp^®. Your health care provider should monitor you closely while you are taking TZDs with Fiasp^®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Common side effects of Fiasp^® may include:

skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis), reactions at the injection site such as itching, rash, skin thickening or pits at the injection site (lipodystrophy), or weight gain.

Please see Prescribing Information for Fiasp at http://www.novo-pi.com/fiasp.pdf

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 novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

References

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 44^th Annual Conference of ISPAD. 11-14 October 2018; Hyderabad, India.
Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2017.