Basal Insulin Tresiba Approved for Teens and Kids as Young as One
By Ava Runge
The FDA decision on Novo Nordisk’s basal insulin is based on positive safety and efficacy data of Tresiba versus other basal insulins
Novo Nordisk recently announced FDA approval of an expanded pediatric indication for Tresiba, meaning that the basal insulin can now be used to treat people with type 1 and type 2 diabetes as young as age one. The label update is based on data from the BEGIN YOUNG 1 trial, which showed Tresiba is safe and effective when used in children with type 1 diabetes (relative to Novo Nordisk’s Levemir). Prior studies have also shown that Tresiba poses a lower risk of severe and overnight hypoglycemia and doesn’t increase the risk of heart disease compared to Sanofi’s Lantus.
European children and adolescents already have access to Tresiba, as the European Medicines Agency previously endorsed this indication in 2014.
Tresiba was launched for adults in the US in January 2016, after a very long and delayed approval process. Tresiba comes in prefilled FlexTouch pens in two concentrations: U100 (meaning one milliliter of insulin contains 100 units of insulin) and U200 (meaning one milliliter of insulin contains 200 units of insulin), and allows for maximum doses of 80 units or 160 units per injection, respectively. It offers several features for people with diabetes on insulin, including:
A flatter blood glucose profile and less hypoglycemia: In certain trials, Tresiba seemed to cause less hypoglycemia than Lantus did. [These trials did not use continuous glucose monitoring (CGM), a tool which can provide a fuller picture of glucose levels and which will hopefully be used more in future insulin studies.]
Dosing Flexibility: Tresiba can be taken at any time throughout the day – for example, 8 am on Monday, 12 pm on Tuesday, and 7 am on Wednesday. The insulin lasts for an impressive 42 hours (at least), and doses must be taken at least eight hours apart. This flexibility is a major plus, as all other basal insulins (Levemir, Lantus, Toujeo) must be taken at the same time every day according to the official instructions.
Fewer Injections for those using high doses of insulin: Users can take up to 160 units of Tresiba in a single injection with the U200 pen, which means even people with significant insulin resistance can take a day’s worth of insulin in a single dose.