FDA okays novel med for children with diabetes

January 10, 2020

Already approved for adult patients, Fiasp is now available for children.

FDA cleared the first and only fast-acting mealtime insulin injection for children that does not have a pre-meal dosing recommendation.

Insulin aspart injection (Fiasp, Novo Nordisk) 100 u/mL is a new mealtime insulin option for children with diabetes. Fiasp was approved by FDA in 2018 for adults and the approval has been expanded to the pediatric population, according to Novo Nordisk.

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The average wholesale acquisition cost for Fiasp is the same as NovoLog, Novo Nordisk’s other mealtime (rapid acting) insulin: $558.83 for a box of 5 pens or $289.36 per 10 mL vial, according to the company.

It is available immediately in 3 different dosing options: multiple daily injections (MDI), continuous subcutaneous insulin infusion pumps, and intravenous infusion under supervision by a healthcare professional.

“Managing diabetes can be challenging for parents and caregivers, given it is hard to know exactly how much or how quickly their children will eat, making mealtime insulin dosing difficult,” Novo Nordisk said in a statement.

Conventional rapid-acting insulins must be administered ahead of meals, “which requires some guesswork to dose properly, and children living with diabetes may not achieve adequate blood sugar control,” Novo Nordisk added.

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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 at Novo Nordisk. "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 approval is based on the FDA's review of data from the onset 7 clinical trial, which confirmed the efficacy and safety of Fiasp in children. 

The 26-week, phase 3b trial investigated the efficacy and safety of Fiasp compared with conventional insulin aspart in 777 children with type 1 diabetes. After 26 weeks of treatment, the treatment difference for change in HbA1c from baseline between mealtime Fiasp compared to mealtime NovoLog, and the treatment difference between postmeal Fiasp compared to mealtime NovoLog met the pre-specified non-inferiority margin (0.4%).

Novo Nordisk is offering co-pay and other patient assistance programs for the drug at myfiaspcost.com. Patients can also take advantage of Novo Nordisk’s insulin savings program, announced last year, which includes 3 vials or 2-packs of FlexPen/FlexTouch/Penfill pens of any combination of insulins from Novo Nordisk for $99.

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