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.

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.

"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 hyperglycaemia 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.

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.

For more details, go to: http://www.novonordisk.com/press/sea/novo-nordisk-news.asp?sShowNewsItemGUID=24117754-d669-41fc-9686-69ff3ce84e8e&sShowLanguageCode=en-GB