New Tresiba® Summary of Product Characteristics: European Commission approves the label expansion to include children with type 1 and type 2 diabetes
In December 2014 Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for expanded use of Tresiba® (insulin degludec) in children and adolescents aged 1-17 years with diabetes. And now, after the approval of the European Commission for the label expansion, physicians in the European Union can prescribe Tresiba® to children with type 1 and type 2 diabetes.
According to the International Diabetes Federation, an estimated 497,100 children are living globally with type 1 diabetes and rates of type 2 diabetes among children are also on the increase1.
“When treating children and adolescents with diabetes, getting patients to target while minimising side effects is always a priority,” said Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, United Kingdom and the lead study investigator of the BEGIN® YOUNG 1 trial. “This latest CHMP recommendation for Tresiba® offers patients between the ages of 1 and 17 a new once-daily basal insulin which allows patients to get to target with a reduced risk of hyperglycemia with ketosis versus insulin detemir.”
The positive CHMP opinion for expanded use of Tresiba® in children and adolescents is based on efficacy and tolerability data from the BEGIN® YOUNG 1 trial, which is the first study to look into the long-term safety of Tresiba® in children with type 1 diabetes. Results show that Tresiba® given once daily in combination with insulin aspart effectively improved long-term glycaemic control2.
Tresiba® was approved in Europe in 2013 for once-daily use in adults with type 1 and type 2 diabetes as a monotherapy and in combination with oral anti-diabetic (OAD) medicinal products or with mealtime insulin. In May 2014, Tresiba® was approved for combination use with GLP-1 receptor agonists3.
References
1. International Diabetes Federation. Diabetes Atlas, sixth edition. The global burden. Available at: http://www.idf.org/sites/default/files/EN_6E_Ch2_the_Global_Burden.pdf Last accessed: November 2014.
2. Thalange N, et al. Long-term efficacy and safety of insulin degludec in combination with bolus insulin aspart in children and adolescents with type 1 diabetes. Diabetologia. 2014;57(Suppl.1): S395.
3. Tresiba® Summary of Product Characteristics. Bagsværd, Denmark, Novo Nordisk A/S; 2015.
