Approvals Sought for Use of Fast-Acting Insulin Aspart in Children

Novo Nordisk is seeking approval for fast-acting insulin aspart (Fiasp) as a new mealtime insulin for children and adolescents with type 1 diabetes.

The company has submitted label updates to the FDA and the European Medicines Agency (EMA) for the new use. The drug is currently indicated for the treatment of type 1 and type 2 diabetes in adults only.

Parents of young children with type 1 diabetes identified mealtimes as 1 of the most problematic areas for managing diabetes. Skipping meals and snacking as an adolescent also pose challenges for diabetes management, according to Novo Nordisk.

"Clinical experience shows that for conventional rapid-acting insulins to work best, they need to be administered ahead of the meal, which might require a lot of guesswork. Fiasp has a faster acting profile of action, compared to conventional insulin aspart, and can be administered at the start of the meal, which can help reduce the guessing around mealtime," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, in a prepared statement. "We believe that Fiasp can help this younger population manage their diabetes."

The company’s submissions are based on results from the onset 7 trial, which investigated the efficacy and safety of its fast-acting insulin aspart compared with conventional insulin aspart in children and adolescents with type 1 diabetes. The 26-week, phase 3b, partially double-blind, basal-bolus, treat-to-target trial, evaluated the drug dosed at mealtime (0-2 minutes before starting the meal) and 20 minutes after the start of the meal, compared with conventional insulin aspart dosed at mealtime, in children and adolescents with type 1 diabetes. All treatment arms involved a multiple daily injection routine (basal-bolus) using insulin degludec as the basal insulin.

The study showed that children and adolescents with type 1 diabetes achieved superior control of overall blood sugar levels (HbA_1c) with fast-acting insulin aspart, as well as significantly lower overall post-meal blood sugar levels (1 hour after the meal), compared to conventional insulin aspart, when both treatments were dosed at mealtime.

In addition, the results in those that injected fast-acting insulin aspart 20 minutes after the start of the meal showed that this drug provided similar control of overall blood sugar levels (noninferior), compared to conventional insulin aspart dosed at mealtime.

Officials with Novo Nordisk said the company anticipates a response from the EMA later this year, and from the FDA in early 2020.

Reference

Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents [news release]. Bagsværd, Denmark; March 1, 2019: Novo Nordisk. https://www.prnewswire.com/news-releases/novo-nordisk-files-for-a-label-update-for-fiasp-to-the-ema-and-the-fda-seeking-approval-for-use-in-children-and-adolescents-300804894.html. Accessed March 1, 2019.