COPENHAGEN, Denmark I December 19, 2014 I 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 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 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 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.
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 diabetes2.
Tresiba® met the primary endpoint of non-inferiority to insulin detemir for mean change in HbA1c (p
About Tresiba®
Tresiba® (insulin degludec) is a once-daily basal insulin that provides an ultra-long duration of action beyond 42 hours3,4. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time when needed3,5,6.
Tresiba® has received regulatory approval in Argentina, Aruba, Azerbaijan, Bangladesh, Bosnia & Herzegovina, Brazil, Chile, Colombia, Costa Rica, El Salvador, the EU, Honduras, Hong Kong, Iceland, India, Israel, Japan, Kazakhstan, Lebanon, Lichtenstein, Macedonia, Mexico, Nepal, Norway, Russia, South Korea, Switzerland and the UAE.
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 287
COPENHAGEN, Denmark I December 19, 2014 I 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 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 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 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.
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 diabetes2.
Tresiba® met the primary endpoint of non-inferiority to insulin detemir for mean change in HbA1c (p
About Tresiba®
Tresiba® (insulin degludec) is a once-daily basal insulin that provides an ultra-long duration of action beyond 42 hours3,4. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time when needed3,5,6.
Tresiba® has received regulatory approval in Argentina, Aruba, Azerbaijan, Bangladesh, Bosnia & Herzegovina, Brazil, Chile, Colombia, Costa Rica, El Salvador, the EU, Honduras, Hong Kong, Iceland, India, Israel, Japan, Kazakhstan, Lebanon, Lichtenstein, Macedonia, Mexico, Nepal, Norway, Russia, South Korea, Switzerland and the UAE.
Novo Nordisk is a healthcare company and a world leader in diabetes care.
In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
SOURCE: Novo Nordisk
Post Views: 287
