Novo Nordisk gets positive CHMP opinion for expanded use of Tresiba in children with diabetes

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 one to 17 years with diabetes. Once the European Commission approves the licence extension, physicians in the European Union will be able to prescribe insulin degludec to children and adolescents aged one to 17 with type 1 and type 2 diabetes.

According to the International Diabetes Federation, an estimated 497,100 children under 15 years are living globally with type 1 diabetes and rates of type 2 diabetes among children are also on the increase.

"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 insulin degludec offers patients between the ages of one and 17 a 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 insulin degludec 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 insulin degludec in children and adolescents with type 1 diabetes. Results show that insulin degludec given once daily in combination with insulin aspart maintained long-term glycaemic control.
Insulin degludec 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, insulin degludec was approved for combination use with GLP-1 receptor agonists.



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