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 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.
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
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.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2019 Novo Nordisk All rights
reserved.
US19FSP00064 February 2019
View original
content:http://www.prnewswire.com/news-releases/novo-nordisk-files-for-a-label-update-for-fiasp-to-the-ema-and-the-fda-seeking-approval-for-use-in-children-and-adolescents-300804894.html
SOURCE Novo Nordisk