Novo Nordisk has announced that the European Commission has granted an extension of the indication for its fast-acting insulin aspart, Fiasp.
The extension is for the treatment of diabetes in adolescents and children (aged one year and above), complementing the previous indication, which covered adults only.
Novo submitted label updates to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the pediatric extension in March this year, after parents reported that mealtimes are a particular stress for children and adolescents with diabetes type I, and skipping meals and snacking also pose challenges for diabetes management.
The submissions were based on the results from the onset 7 trial which investigated the efficacy and safety of the drug compared to conventional insulin aspart in children and adolescents with type I diabetes.
The trial consisted of 777 people all of whom were children or adolescents with type I diabetes, and found that the participants achieved superior control of overall blood sugar levels with Fiasp, as well as significantly lower overall post-meal blood sugar levels one hour after the meal. Both of these were compared to conventional insulin aspart, when dosed at mealtime.
The company are “very pleased with the decision of the European Commission to expand the indication of Fiasp, making it available within this younger population,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
He continued, “With this expanded indication, we hope that adolescents and children who are at least one-year-old will find in Fiasp a good option in the management of their diabetes.”
For the new paediatric indication, it is recommended that the treatment is administered prior to the meal (0-2 minutes before the start of the meal). The company reminds that however, Fiasp can also be administered up to 20 minutes after the start of a meal (post-meal dosing) in situations when there is uncertainty about the meal intake. Close monitoring of blood sugar levels is advised when dosing Fiasp post-meal at dinner time to avoid nocturnal hypoglycaemia (low blood sugar levels).
The drug is the only approved, new-generation, ultra-fast acting mealtime insulin injection.