FDA approves first fast-acting mealtime insulin for children

The U.S. Food and Drug Administration (FDA) has approved Fiasp^® (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes. It is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp^® is administered at the beginning of a meal or within 20 minutes after starting a meal.

Fiasp^® is now available for use in children and adults in three different dosing options: multiple daily injections (MDI), continuous subcutaneous insulin infusion pumps and intravenous infusion under supervision by a healthcare professional.

Diabetes is one of the most common chronic conditions diagnosed in childhood, with nearly 18,000 new cases of type 1 diabetes each year. 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. 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.

Approval of the therapy is based on the FDA’s review of data from the Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes (onset 7) study. Onset 7 was a 26-week, phase 3b, partially double-blind, basal-bolus, a treat-to-target trial examining the efficacy and safety of insulin aspart injection 100 u/mL against conventional insulin aspart in children with type 1 diabetes.

"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 U.S. chief medical officer of Novo Nordisk. "Children can be unpredictable and having the option of fast-acting insulin that doesn't require pre-meal dosing like Fiasp^® is a welcome development for the diabetes community."

The therapy is not recommended for patients experiencing episodes of hypoglycemia or patients hypersensitive to insulin aspart or one of the excipients in insulin aspart injection 100 u/mL.