FDA OKs Fast-Acting Insulin Aspart Injection for Children with Diabetes

Officials with the FDA today approved Novo Nordisk’s insulin aspart injection (Fiasp) 100 u/mL for use as a new mealtime insulin option for children with diabetes, according to a press release.¹

Insulin aspart injection 100 u/mL is available for use in children and adults as multiple daily injections, continuous subcutaneous insulin infusion pumps, and intravenous infusion under supervision by a health care professional.¹

The expanded indication is based on data from the onset 7 clinical trial, a 26-week, phase 3b study which investigated the efficacy and safety of insulin aspart injection compared with conventional insulin aspart (IAsp) in 777 children with type 1 diabetes. The study results were published in Diabetes Care.²

According to the findings, at week 26, mealtime and postmeal fast-acting insulin aspart (faster aspart) were noninferior to IAsp regarding changes from baseline HbA_1c (P<0.001 for noninferiority [0.4% margin]), with a statistically significant difference in favor of mealtime faster aspart (estimated treatment difference -0.17% [95% CI -0.30; -0.03], -1.82 mmol/mol [-3.28; -0.36]; P=0.014). Additionally, changes from baseline in 1-h postprandial glucose increment significantly favored mealtime faster aspart versus IAsp at breakfast, main evening meal, and overall meals (P<0.01 for all).²

No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed in the study. Mean total daily insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp.

“The continuous improvement in long-term glycemic control, management of hypoglycemia risk, and dosing flexibility with intensified insulin therapy is imperative in children and adolescents,” the study authors wrote.²

According to Novo Nordisk, insulin aspart injection 100 u/mL is the first fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.¹

“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,” Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, said in a statement.² “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.