The US Food and Drug Administration (FDA) has approved an expanded indication for Novo Nordisk’s diabetes drug Tresiba (insulin degludec).
Tresiba, a once-daily, long-acting basal insulin, is already approved for use in Europe and the US by people with either type 1 diabetes or type 2 diabetes.
This new FDA indication – which approves Tresiba for use in children and adolescents with diabetes – was made nearly two years ago by the European Commission.
Novo Nordisk has since been striving to attain similar approval from the FDA, and submitted their supplemental New Drug Application based on the results of a trial called BEGIN Young 1.
The trial compared the effects of Tresiba with Levemir, both administered once- or twice-daily in combination with insulin apart at mealtimes. The aim was to see if Tresiba can improve glycemic control in children who had type 1 diabetes and were aged between 1-17 years.
After 26 weeks, Tresiba was shown to effectively improve blood sugar levels in combination with insulin aspart (sold as NovoRapid in the UK and as NovoLog in the US).
“It can be challenging for children with type 1 diabetes and their parents to manage blood sugar levels and keep up with multiple injections throughout an already busy day. With this approval, they now have another option of a long-acting insulin that is dosed once daily,” said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk.
Novo Nordisk also reports that the use of Tresiba in children with type 2 diabetes aged one year and older is supported by evidence from studies in adults with type 2 diabetes.
The drug is the only basal insulin to be approved for both type 1 diabetes and type 2 diabetes. in patients as young as one.
