FDA Approves Insulin Aspart Injection for Children with Diabetes

January 6th 2020

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.

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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.

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"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.

"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 ."

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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.

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

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REFERENCE

  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.
  2. 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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