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

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


CHMP, has adopted a positive opinion to extend the use of NovoRapid(R) (insulin aspart)


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


ages[1]. The clinical needs of young children with type 1 diabetes vary during growth


development. This may present challenges to clinicians who need to find an appropriate

treatment regimen that maintains adequate metabolic control while avoiding the


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


year old means that once the European Commission approves this label extension,


may soon have access to a well-trusted mealtime insulin to help manage this patient


The CHMP recommendation for expanded use of NovoRapid(R) in children aged one year


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


between treatment groups or between age groups[3],[4]. Data also showed that


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


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


above[5],[6]. NovoRapid(R) can be used in pregnancy. NovoRapid(R) has been available


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


leadership in diabetes care. This heritage has given us experience and capabilities


also enable us to help people defeat other serious chronic conditions: haemophilia,


disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately


people in 75 countries and markets its products in more than 180 countries. For more

information, visit [ ], Facebook

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LinkedIn [ ], YouTube

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Further information    

Katrine Sperling         
+45 4442 6718 

Asa Josefsson            
+45 3079 7708  
Peter Hugreffe Ankersen  
+45 3075 9085 

Melanie Raouzeos         
+45 3075 3479 

Hanna Ögren              
+45 3079 8519 

Kasper Veje (US)         
+1 609 235 8567



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


1) International Diabetes Federation. IDF Diabetes Atlas, seventh edition. Available
[ ]. Last accessed: September
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.

Novo Nordisk

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