Levemir® Receives Positive CHMP Opinion for Extended Use in Children as Young as One Year Old

Bagsværd, Denmark (ots/PRNewswire) -

Novo Nordisk today announced that the Committee for Medicinal
Products for Human Use (CHMP) has issued a positive opinion for the
expanded use of Levemir(R) (insulin detemir) in children with
diabetes as young as one year old.

(Logo: http://photos.prnewswire.com/prnh/20141103/713759 )

There are an estimated 497,100 children living with type 1
diabetes globally and incidence is increasing in many countries[1].
Young children with type 1 diabetes can be difficult to treat as
their needs are in constant flux during growth and development[2],
with children aged six and under at greatest risk of severe
hypoglycaemia and acute diabetes complications[3].

"Treating very young children with diabetes is challenging and it
is crucial to strike a balance between achieving glucose targets,
while minimising risk of side effects, particularly hypoglycaemia,"
said Dr Nandu Thalange, paediatric endocrinologist at Norfolk and
Norwich University Hospital, Norwich, United Kingdom and lead study
investigator of the BEGIN(R) YOUNG 1 trial. "This CHMP recommendation
for use of Levemir(R) in children as young as one, gives clinicians
another option for this very young age group."

The CHMP recommendation for expanded use of Levemir(R) in children
is based on data from the BEGIN(R) YOUNG 1 trial, which evaluated the
efficacy and long-term safety of Levemir(R) and insulin degludec in
children and adolescents with type 1 diabetes. Results show that
Levemir(R), once or twice daily, in combination with insulin aspart,
effectively improved long-term glycaemic control compared to
baseline, and was well tolerated in children and adolescents with
type 1 diabetes, including those as young as one year old[2].

"Novo Nordisk is committed to improving diabetes management for
people with diabetes of all ages," said Jakob Riis, executive vice
president, Novo Nordisk. "Levemir(R) has been shown to be effective
and well tolerated in children and adults with diabetes and we are
pleased that once the European Commission approves this label
expansion there will be another basal insulin option for children as
young as one in the European Union."

Novo Nordisk expects to receive marketing authorisation from the
European Commission within two to three months.

About the study

The BEGIN(R) YOUNG 1 trial was a randomised controlled, 26-week
open-label, treat-to-target trial (with a 26-week extension)
investigating the efficacy and safety of Levemir(R), given once or
twice daily, and insulin degludec, given once daily, both in
combination with bolus insulin aspart in children and adolescents
aged 1-17 years with type 1 diabetes[2].

Levemir(R) and insulin degludec both achieved long-term glycaemic
control as measured by mean change in HbA1c at 26 weeks[2]. Both
treatments were well tolerated with comparable rates of adverse
events[2]and similar rates of overall and nocturnal hypoglycaemia[2].
Weight (measured as SD score*) remained unchanged with Levemir(R)[2].

About Levemir(R)

Levemir(R) (insulin detemir) is a long-acting basal insulin for
the treatment of diabetes[4]. Levemir(R) was launched in 2004 and is
commercially available in 90 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 39,000 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 ].

_______________________

* Standard deviation (SD) measures the amount of variation from
the average. A low standard deviation indicates that the data points
are close to the average; a high standard deviation indicates that
the data points are spread out over a large range of values.

References

1. International Diabetes Federation. Diabetes Atlas, sixth
edition. The global burden. Available at: http://www.idf.org/sites/de
fault/files/EN_6E_Ch2_the_Global_Burden.pdf. Last accessed: May 2015.

2. 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.

3. Rewers A, et al. Predictors of acute complications in children
with type 1 diabetes. JAMA. 2002;287:2511-2518.

4. Blonde L, et al. Patient-directed titration for achieving
glycaemic goals using a once-daily basal insulin analogue: an
assessment of two different fasting plasma glucose targets - the
TITRATE study. Diabetes Obes Metab. 2009;11:623-31.

Photo:
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ots Originaltext: Novo Nordisk A/S
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Contact:
Further information: Media: Katrine Sperling, +45 4442 6718,
krsp@novonordisk.com; Investors: Kasper Roseeuw Poulsen, +45 3079
4303,
krop@novonordisk.com; Daniel Bohsen, +45 3079 6376,
dabo@novonordisk.com;
Melanie Raouzeos, +45 3075 3479, mrz@novonordisk.com; Frank Daniel
Mersebach (US), +1 609 235 8567, fdni@novonordisk.com