FDA Approves Fiasp for Children With Diabetes


The FDA expanded the use of Fiasp, a fast-acting insulin aspart injection, in children as young as 2 years to treat diabetes. First approved for adults in 2017, Novo Nordisk said it is the only "mealtime insulin injection that does not have a pre-meal dosing recommendation.”

On January 6, the FDA approved the use of Fiasp, an insulin aspart injection, in children as young as 2 years to treat diabetes.

The treatment, from Novo Nordisk, was approved for use in adults in 2017. It is the “first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation,” according to the company’s press release.

Fiasp can be administered 3 ways: as multiple daily injections, through continuous subcutaneous insulin infusion pumps, and via intravenous infusion under the supervision of a healthcare professional. The treatment can also be administered anytime from the start of a meal to up to 20 minutes after the meal is finished. Because Fiasp is already on the market for adults, the treatment is readily available to children. The cost of the treatment also is the same for adults and children.

In an interview with The American Journal of Managed Care®, Todd Hobbs, MD, vice president and chief medical officer of Novo Nordisk in North America, said, “We know that in particular, children and mealtimes are very challenging, whether it be a 4-year-old toddler or a teenager.”

For this reason, it was important to expand the treatment’s availability. “We know that flexibility and the dose timing around that meal is important,” he said.

As a parent to a son with type 1 diabetes, Hobbs gave firsthand perspective on how dosing at mealtimes can be difficult.

“There’s almost a little bit of a guilt if you’re a parent or a caregiver because you can’t always dose ahead of time. If you look at our insulins throughout history, in human insulin, which we’ve used for decades, it should be dosed almost 45 minutes before the meal. It’s never possible really to do that. Even with more modern insulins, for children to dose 15 or more minutes before they eat is really challenging for parents and school nurses,” said Hobbs, who also has type 1 diabetes.

The most important aspect of the treatment, according to Hobbs, is that it gives parents and providers peace of mind when it comes to children’s insulin dosing and eating.

“Even if they need to wait a few minutes afterwards to see if their child is eating and hungry, they can do that without having to worry about the pre-meal dosing time and all the things that go into that,” he said.

“We certainly don’t expect that this is necessarily going to make a big splash in the insulin marketplace at this time,” said Hobbs when asked about the success of the treatment. “But what we hope for is that those individuals, families, patients, and children especially, who need that control and reassurance around the meal, that it’s really going to offer them the option to do that.”

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