The U.S. Food and Drug Administration has approved Novo Nordisk’s fast-acting Fiasp insulin aspart for use in children as well as adults, the pharmaceutical firm announced Monday.
Fiasp insulin is approved for use with both the primary delivery methods for insulin: multiple daily injections (MDI) and continuous subcutaneous infusion via an insulin pump. It may also be injected intravenously under hospital supervision.
“As a parent of a son living with type 1 diabetes, I know first-hand how tough it can be to address the inevitable blood sugar spikes around mealtimes,” Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk, said in a press release. “Children can be unpredictable and having the option of a fast-acting insulin that doesn’t require pre-meal dosing like Fiasp is a welcome development for the diabetes community.”
The insulin had previously been approved for use in adults, but more research was necessary to make the determination that it would also be safe in children, who typically receive smaller boluses, eat less food, and are more susceptible to dramatic blood sugar fluctuations.
Insulin at mealtimes, rather than before them
Fiasp is differentiated from other fast-acting insulins such as Humalog or Novolog in that is designed to be dosed directly at the beginning of a meal – or even up to 20 minutes after you begin eating – rather than some number of minutes prior to the meal.
For people using insulin pumps or calculating “insulin on board,” it is worth noting that the faster uptake and action of Fiasp means that it also metabolizes and leaves the blood stream differently. While its overall duration is comparable to other fast-acting insulins, the curve and speed of action will differ, especially during the first hour.
Novolog received the approval after conducting a 26-week, partially doubleblind trial that examined both the safety and the effectiveness of Fiasp compared to other fast-acting insulins in a cohort of 777 children with type 1 diabetes.
In October, the FDA approved Fiasp for usage in insulin pumps, putting it into more direct competition with other insulin formulations, and the medication was approved for use in children in Europe in September 2019.