FDA Expands Tresiba Indication to Children and Adolescents With Diabetes

Patrice Wendling

December 20, 2016

The US Food and Drug Administration has given the nod to use Novo Nordisk's long-lasting insulin degludec (Tresiba) in patients with diabetes mellitus from age 1 year through adulthood, according to a company press release.

Once-daily Tresiba has a half-life of 25 hours and is available as a 100-U/mL or 200-U/mL pen.

The new indication was based on the phase 3b BEGIN Young 1 trial showing that once-daily administration of Tresiba in combination with insulin aspart, a mealtime insulin, improved glycemic control in children and adolescents with type 1 diabetes aged 1 to 17 years when compared with insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) given once or twice daily, also in combination with insulin aspart. The most common adverse events in the trial were infection, hypoglycemia, and hyperglycemia.

The use of Tresiba in patients 1 year and older with type 2 diabetes is supported by data from studies in adults with type 2 diabetes, the report notes.

In the press release, Novo Nordisk chief medical officer Todd Hobbs, MD, commented, "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."

Tresiba is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of the drug.

The long-acting insulin was first approved in September 2015 to improve blood glucose control in adults on the basis of interim data from the DEVOTE trial.

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