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FDA: Tresiba approved for use in children, adolescents
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The FDA recently approved an expanded indication for insulin degludec injection, a once-daily, long-acting basal insulin, for use in children and adolescents with diabetes, according to a press release from Novo Nordisk.
The insulin degludec injection, known as Tresiba, is now the only basal insulin approved for both type 1 and type 2 diabetes in patients aged 1 year or older.
“We are seeing a risk in the number of children and adolescents with diabetes in the [United States], especially those with type 2, we are proud to support these patients by offering new and effective treatment options,” Todd Hobbs, MD, chief medical officer of Novo Nordisk, said in the release. “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 long-acting insulin that is dosed once daily.”
The approval comes after the New Drug Application was submitted based on results from the BEGIN Young 1 trial, which compared the efficacy and safety of Tresiba with insulin detemir (Levemir) in combination with insulin aspart in children and adolescents with type 1 diabetes aged 1 to 17 years. Tresiba was shown to effectively improve glycemic control, and the most common adverse events were infection, hypoglycemia and hyperglycemia.