FDA Approves Mealtime Insulin Injection for Children

Novo Nordisk has announced the United States Food and Drug Administration (FDA) granted insulin aspart injection 100 u/mL (Fiasp®) approval for the improvement of glycemic control in pediatric patients with diabetes mellitus.

With Monday’s approval the insulin aspart injection, which has previously received approval for adult patients, is the first fast-acting mealtime insulin injection without a pre-meal dosing recommendation for pediatric patients.

"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. "Children can be unpredictable and having the option of a fast-acting insulin that doesn't require pre-meal dosing like (insulin aspart injection 100 u/mL) is a welcome development for the diabetes community."

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, according to a press release from Novo Nordisk. Onset 7 was a 26-week, phase 3b, partially double-blind, basal-bolus, 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.

Results of the trial, which included 777 children, indicated insulin aspart injection provided effective glycemic control with no additional safety risks. Following Monday’s approval, insulin aspart injection 100 u/mL is now approved for multiple daily injections, continuous subcutaneous insulin infusion pumps and intravenous infusion under supervision by a healthcare professional in adults and children, according to Novo Nordisk’s release.

The release went on to note insulin aspart injection 100 u/mL be used at the beginning of a meal or within 20 minutes after starting a meal. Additionally, 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.