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news.Novo Nordisk secured approval from the US Food and Drug Administration (FDA) for an expanded use for Tresiba (insulin degludec) injection to improve glycemic control in children and adolescents with both type 1 and type 2 diabetes.
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Tresiba, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood, making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old.
Tresiba is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.
Novo Nordisk U.S. chief medical officer Todd Hobbs, M.D. said: "We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options.
"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."
Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension.
BEGIN Young 1 compared the efficacy and safety of Tresiba administered once-daily compared with Levemir (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart, a mealtime insulin, in children and adolescents with type 1 diabetes aged 1 to 17.
The results showed that Tresiba in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia and hyperglycemia.
The use of Tresiba in patients one year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.
Once-daily Tresiba (insulin degludec injection 100 U/mL, 200 U/mL) is available in Novo Nordisk's latest insulin delivery device – FlexTouch – as a 100 units/mL or 200 units/mL pen.
Tresiba U-100 FlexTouch can deliver up to 80 units of insulin in a single injection. Tresiba U-200 FlexTouch can dose up to 160 units in a single injection. FlexTouch is also the only prefilled insulin pen with no push-button extension.
Eligible patients with commercial insurance can use the Tresiba Instant Savings Card to reduce co-pays to as low as $15 a month for up to 24 months. Eligibility and other restrictions apply.
Indications and Usage
Tresiba is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.
Limitations of Use
Tresiba is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of Tresiba.
What is Tresiba?
- Prescription Tresiba is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes
- Tresiba is not for people with diabetic ketoacidosis
- Tresiba is not for children who need less than 5 units of Tresiba each day
- It is not known if Tresiba is safe and effective in children under 1 year of age
- Tresiba is available in 2 concentrations: 200 units/mL and 100 units/mL