FDA Expands Indication of Insulin for Younger Diabetes Patients

The FDA recently approved an expanded indication for Tresiba (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes.

The insulin is now indicated to improve blood glucose levels in type 1 and type 2 diabetes in patients as young as 1-year-old, making it the only basal insulin approved in these patients, according to a press release from Novo Nordisk.

Tresiba is a long-acting basal insulin administered through injection once per day. The insulin has a 25-hour half-life, and has demonstrated a consistently stable profile.

The new drug application was submitted based on positive results from the phase 3b BEGIN Young 1 trial. The 26-week trial evaluated the efficacy and safety of once-daily Tresiba compared with Levemir (insulin detemir [rDNA origin] injection) administered once or twice daily in combination with a mealtime insulin (insulin aspart).

Included in the randomized trial were patients with type 1 diabetes whose ages ranged from 1- to 17-years-old. The investigators found that Tresiba in combination with insulin aspart improved glycemic control in these patients, according to Novo Nordisk. Common adverse events seen in the trial included infection, hypoglycemia, and hypoglycemia.

Novo Nordisk said that other common adverse events have included reactions at injection site, itching, rash, allergic reactions, lipodystrophy, weight gain, and swelling of the hands and feet. Tresiba may also cause heart failure in patients taking thiazolidinediones for type 2 diabetes.

Additionally, Novo Nordisk reported that the use of Tresiba in patients age 1 and older who have type 2 diabetes is supported by findings from previous studies that included adults.

However, the insulin is not recommended for patients with keatoacidosis, or young patients who do not need more than 5 units of insulin per day. It is currently unknown whether Tresiba is safe and effective in patients who are younger than 1-year-old.

Tresiba is available in the FlexTouch device as a 100 units/mL or 200 units/mL pen, which is the only prefilled insulin pen without a push-button extension, according to the press release. The U-100 FlexTouch can deliver up to 800 units in 1 injection, and the U-200 FlexTouch can deliver up to 160 units per injection.

Novo Nordisk warns patients not to share their Tresiba FlexTouch with others due to a potential risk for developing a serious infection.

Patients with commercial insurance may qualify for the Tresiba Instant Savings Card that reduces co-pays for the drug as low as $25, according to Novo Nordisk.

"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," said Todd Hobbs, MD, US chief medical officer at Novo Nordisk. "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."