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Levemir® Receives Positive CHMP Opinion for Extended Use in Children as Young as One Year Old
Bagsværd, Denmark (ots/PRNewswire) - Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the expanded use of Levemir(R) (insulin detemir) in children with diabetes as young as one year old.
There are an estimated 497,100 children living with type 1 diabetes globally and incidence is increasing in many countries. Young children with type 1 diabetes can be difficult to treat as their needs are in constant flux during growth and development, with children aged six and under at greatest risk of severe hypoglycaemia and acute diabetes complications.
"Treating very young children with diabetes is challenging and it is crucial to strike a balance between achieving glucose targets, while minimising risk of side effects, particularly hypoglycaemia," said Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, United Kingdom and lead study investigator of the BEGIN(R) YOUNG 1 trial. "This CHMP recommendation for use of Levemir(R) in children as young as one, gives clinicians another option for this very young age group."
The CHMP recommendation for expanded use of Levemir(R) in children is based on data from the BEGIN(R) YOUNG 1 trial, which evaluated the efficacy and long-term safety of Levemir(R) and insulin degludec in children and adolescents with type 1 diabetes. Results show that Levemir(R), once or twice daily, in combination with insulin aspart, effectively improved long-term glycaemic control compared to baseline, and was well tolerated in children and adolescents with type 1 diabetes, including those as young as one year old.
"Novo Nordisk is committed to improving diabetes management for people with diabetes of all ages," said Jakob Riis, executive vice president, Novo Nordisk. "Levemir(R) has been shown to be effective and well tolerated in children and adults with diabetes and we are pleased that once the European Commission approves this label expansion there will be another basal insulin option for children as young as one in the European Union."
Novo Nordisk expects to receive marketing authorisation from the European Commission within two to three months.
About the study
The BEGIN(R) 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 Levemir(R), given once or twice daily, and insulin degludec, given once daily, both in combination with bolus insulin aspart in children and adolescents aged 1-17 years with type 1 diabetes.
Levemir(R) and insulin degludec both achieved long-term glycaemic control as measured by mean change in HbA1c at 26 weeks. Both treatments were well tolerated with comparable rates of adverse eventsand similar rates of overall and nocturnal hypoglycaemia. Weight (measured as SD score*) remained unchanged with Levemir(R).
Levemir(R) (insulin detemir) is a long-acting basal insulin for the treatment of diabetes. Levemir(R) was launched in 2004 and is commercially available in 90 countries.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,000 people in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com], Facebook [http://www.facebook.com/novonordisk], Twitter [http://www.twitter.com/novonordisk], LinkedIn [http://www.linkedin.com/company/novo-nordisk], YouTube [http://www.Youtube.com/novonordisk].
* Standard deviation (SD) measures the amount of variation from the average. A low standard deviation indicates that the data points are close to the average; a high standard deviation indicates that the data points are spread out over a large range of values.
1. International Diabetes Federation. Diabetes Atlas, sixth edition. The global burden. Available at: http://www.idf.org/sites/default/files/EN_6E_Ch2_the_Global_Burden.pdf. Last accessed: May 2015.
2. Thalange N, et al. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatric Diabetes. 2015;16:164-176.
3. Rewers A, et al. Predictors of acute complications in children with type 1 diabetes. JAMA. 2002;287:2511-2518.
4. Blonde L, et al. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009;11:623-31.
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