EC backs expanded approval of Novo Nordisk’s Tresiba for children

Danish diabetes care giant Novo Nordisk (NOV: N) says that the European Commission has approved the expanded use of Tresiba (insulin degludec) for children and adolescents with diabetes aged one to 17 years. The extension to the licence is available to patients in the UK with immediate effect.

The approval for expanded use of insulin degludec in children and adolescents is based on efficacy and tolerability data from the BEGINY OUNG 1 trial, which was presented on Wednesday at the Diabetes UK Professional Conference. The BEGIN YOUNG 1 study is the first to look into the long-term safety of insulin degludec in children with type 1 diabetes. Results show that insulin degludec given once daily in a basal-bolus regimen with insulin aspart effectively maintained long-term glycemic control.

Nandu Thalange, pediatric endocrinologist at Norfolk and Norwich University Hospital, and lead study investigator for the BEGIN YOUNG 1 trial said: “When treating children and adolescents with diabetes, getting patients to target while minimizing side effects is a key priority. However, a large proportion of younger people with diabetes are unable to achieve this effectively with current insulin options.”