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Published on 16 September 2016

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NovoRapid® receives positive CHMP opinion for extended use in children 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 EC for final regulatory decision, expected within two months.

 

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.


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