On December 19, 2016, Novo Nordisk announced that the FDA ap | Figure 1
PedroPharmacist
Pharmacist
On December 19, 2016, Novo Nordisk announced that the FDA approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Trial, 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.
Todd Hobbs, MD, US Chief Medical Officer, Novo Nordisk said that "we are seeing a rise in the number of children and adolescents with diabetes in the US, especially those with type 2, and are proud to support these patients by offering new and effective treatment options." The great challenge is 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.
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