NovoRapid® receives positive CHMP opinion for extended use in children as young as one year old

Bagsværd, Denmark (ots/PRNewswire) -

This material is intended for global medical media only.

For journalistic assessment and preparation before publication.

Novo Nordisk today announced that the Committee for Medicinal
Products for Human Use, CHMP, has adopted a positive opinion to
extend the use of NovoRapid® (insulin aspart) in the European Union
for children with diabetes from as young as one year old.

Europe has the highest number of children with type 1 diabetes
with approximately 140,000 cases and evidence shows that children are
continually being diagnosed at younger ages[1]. The clinical needs of
young children with type 1 diabetes vary during growth and
development. This may present challenges to clinicians who need to
find an appropriate treatment regimen that maintains adequate
metabolic control while avoiding the unnecessary risk of
hypoglycaemia[2],[3].

"Up to now there has not been an approved fast-acting mealtime
insulin for children with diabetes as young as one year old," says
Professor Thomas Danne, Auf der Bult Children's Hospital, Hannover,
Germany. "NovoRapid® has a long, proven safety and efficacy profile
for the treatment of diabetes in adults, adolescents and children.
The positive CHMP opinion for the extended use of NovoRapid® in
children from the age of one year old means that once the European
Commission approves this label extension, clinicians may soon have
access to a well-trusted mealtime insulin to help manage this patient
group."

The CHMP recommendation for expanded use of NovoRapid® in children
aged one year and above is based on the BEGIN YOUNG 1 and BOOST T1D
Paediatric trials, which investigated the efficacy and safety of
insulin degludec and insulin degludec/insulin aspart
respectively[3],[4]. In both studies, the comparator was insulin
detemir.

The trial outcomes showed similar glycaemic control in terms of
reducing HbA1c either between treatment groups or between age
groups[3],[4]. Data also showed that NovoRapid® was well-tolerated in
children and adolescents with type 1 diabetes, including those as
young as one year old[3],[4].

The positive CHMP opinion will be sent to the European Commission
(EC) for a final regulatory decision. The positive CHMP opinion will
be sent to the EC for final regulatory decision, expected within two
months.

About NovoRapid®

NovoRapid® (insulin aspart) is a mealtime insulin analogue
indicated for the treatment of diabetes mellitus in adults,
adolescents and children aged two years old and above[5],[6].
NovoRapid® can be used in pregnancy. NovoRapid® has been available
for use in Europe since 1999 and has been launched in more than 120
countries.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to help
people defeat other serious chronic conditions: haemophilia, growth
disorders and obesity. Headquartered in Denmark, Novo Nordisk employs
approximately 42,300 people in 75 countries and markets its products
in more than 180 countries. For more information, visit
novonordisk.com (http://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.youtube.com/novonordisk)

Further information

Media:

Katrine Sperling

+45 4442 6718

krsp@novonordisk.com

Åsa Josefsson

+45 3079 7708

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45
3075 9085

phak@novonordisk.com

Melanie Raouzeos

+45
3075 3479

mrz@novonordisk.com

Hanna Ögren

+45
3079 8519

haoe@novonordisk.com

Kasper Veje (US)

+1
609 235 8567

kpvj@novonordisk.com

All trademarks used or mentioned in this release are legally
protected.

References

1. International Diabetes Federation. IDF Diabetes Atlas, seventh
edition. Available at:
www.diabetesatlas.org/resources/2015-atlas.html. Last accessed:
September 2016.
2. Daneman MB, et al. The infant and toddler with diabetes:
Challenges of diagnosis and management.Paediatr Child Health 1999;
4(1):57-63.
3. Thalange N, et al. Insulin degludec in combination with bolus
insulin aspart is safe and effective in children and adolescents
with type 1 diabetes. Pediatric Diabetes. 2015; 16:164-176.
4. Battelino T, et al. Efficacy and safety of a fixed combination of
insulin degludec/insulin aspart in children and adolescents with
type 1 diabetes. Poster presented at: European Society for
Paediatric Endocrinology - 54th Annual Meeting; 2015 Oct 1-3;
Barcelona, Spain.
5. Rodbard H, et al. Treatment intensification with stepwise addition
of prandial insulin aspart boluses compared with full basal-bolus
therapy (FullSTEP Study): a randomised, treat-to-target clinical
trial. Lancet Diabetes Endocrinol 2014; 2:30-7.
6. NovoRapid® Summary of product characteristics. Bagsværd, Denmark,
Novo Nordisk A/S; Date: July 2016.

Internet:

www.novonordisk.com

CVR no: 24 25 67 90

ZINC: HQMMA/NR/0816/0262

Date of Preparation:
September 2016

ots Originaltext: Novo Nordisk A/S
Im Internet recherchierbar: http://www.presseportal.de