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

January 6, 2020

Insulin aspart injection (Fiasp, Novo Nordisk) has been approved for use as a new mealtime insulin option 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 HbA1c (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.