The expanded use for Novo Nordisk's new basal insulin comes 15 months after the initial FDA approval.
Novo Nordisk has gained FDA approval for children and adolescents to use Tresiba (insulin degludec), the long-acting, once-a-day basal insulin that is the successor to Lantus.
Tresiba, approved by FDA in September 2015, is approved to improve glycemic control in patients with type 1 and type 2 diabetes from the age of 1 year through adulthood, making it the only insulin approved in both types of diabetes for patients that young.
A key advantage of Tresiba, its 25-hour half-life, would give young patients and their parents the flexibility of dosing just once a day.
“We are seeing a rise in the number of children and adolescents in the United States, especially those with type 2, and are proud to support these patients by offering new and effective treatment options,” said Todd Hobbs, MD, US chief medical officer for Novo Nordisk, in a statement. “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.”
FDA’s action was based on results of the BEGIN Young trial, a 26-week, phase 3b, randomized controlled trial which compared Tresiba’s results with those of Levemir (insulin determir, rDNA origin), a long-acting insulin analogue from Novo Nordisk approved in 2005. The results found that Tresiba improved glycemic control effectively in patients age 1 to 17 in combination with insulin aspart, a mealtime insulin.