FDA Approves Insulin Aspart Injection for Children with Diabetes


The treatment is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation, according to Novo Nordisk.

Officials from the FDA have approved insulin aspart injection 100 u/mL (Fiasp, Novo Nordisk) for use as a mealtime insulin option for children with diabetes. The treatment is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation, according to Novo Nordisk.1

The insulin aspart injection is available in 3 dosing options, including: multiple daily injections, continuous subcutaneous insulin infusion pumps, and intravenous infusion under supervision by a health care professional. It was previously indicated for the treatment of type 1 and type 2 diabetes in adults only.2

"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," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, in a prepared statement.1 "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 FDA’s approval of insulin aspart injection for children is based on the agency’s review of data from the onset 7 clinical trial. The 26-week, phase 3b, partially double-blind trial investigates the efficacy and safety of insulin aspart injection in comparison with conventional insulin aspart in 777 children with diabetes.1

Common adverse effects include dermatitis, lipodystrophy, or weight gain. Serious side effects may include hypoglycemia, hypokalemia, serious allergic reactions, and heart failure.1


  • FDA approves Fiasp for treatment of children with diabetes [news release]. Plainsboro, NJ; Novo Nordisk: January 6, 2020. https://www.novonordisk-us.com/media/news-releases.html?122980. Accessed January 6, 2020.
  • Coppock K. Approvals Sought for Use of Fast-Acting Insulin Aspart in Children. Pharmacy Times. https://www.pharmacytimes.com/resource-centers/diabetes/approvals-sought-for-use-of-fastacting-insulin-aspart-in-children. Published March 1, 2019. Accessed January 6, 2020.

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