BAGSVÆRD, Denmark, September 16, 2016 /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(R) (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(R) 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(R) 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(R) 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(R)
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(R)
NovoRapid(R) (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(R) can be used in pregnancy. NovoRapid(R) 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
Asa 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
[http://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(R) Summary of product characteristics. Bagsværd, Denmark, Novo Nordisk
A/S; Date: July 2016.
