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

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.




Novo Nordisk

PR Newswire

Dit persbericht is via ANP Pers Support naar internationale (vak en online) media gestuurd. Heb je nieuws voor buitenlandse journalisten? Bekijk dan onze mogelijkheden of neem contact met ons op.

Verstuur nu éénmalig een persbericht

Verstuur persberichten en beeldmateriaal naar redacties in binnen- en buitenland. Via het ANP-net, het internationale medianetwerk van PR Newswire of met een perslijst op maat.

Direct persbericht versturen
070 - 41 41 234