Tresiba® receives positive opinion from CHMP for treatment of children with diabetes

COPENHAGEN, Denmark, December 19, 2014 /PRNewswire/ - Novo Nordisk today 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. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Tresiba® to children with type 1 and type 2 diabetes.

To view the Multimedia News Release, please click: http://www.multivu.com/players/English/7402051-tresiba-CHMP-children-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 increase[1].

"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 control[2].

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 agonists[3].

About the study 

The BEGIN® YOUNG 1 trial was a randomised controlled, 26-week open-label, treat-to-target trial (with a 26-week extension) investigating the efficacy and safety of Tresiba®, given once daily, and insulin detemir, given once or twice daily, both in combination with bolus insulin aspart in children and adolescents with type 1 diabetes[2].

Tresiba® met the primary endpoint of non-inferiority to insulin detemir for mean change in HbA1c (p