Fiasp – ultrafast acting insulin aspart injection – New approved paediatric indication

Fiasp (manufactured by Novo Nordisk) is a new ultrafast-acting insulin drug that allows for safe and effective control of blood glucose rising rapidly after meals. Diabetes patients often have difficulty controlling post-meal blood glucose, barring them from reaching HbA1c target goals.

The additions of vitamin B3 (niacinamide) and L-arginine amino acid to existing fast-acting insulin (Novo Rapid) makes the initial action twice as fast.

New indication was approved by EU, US and South Korea regulators based on the ONSET 7 study, participated in by 777 patients – children and adolescents with type-1 diabetes, which showed that Fiasp has comparable glycemic control compared to conventional fast-acting insulin, such as Novorapid, with no additional safety risks.

Diabetes is a chronic disease that requires lifelong management. In type 1 pediatric diabetes, basal and dietary insulin fortification therapy is essential as insulin-producing pancreatic beta cells do not produce insulin.

However, pediatric diabetics have a poor ability to manage the disease, making it difficult to predict and control meal volume and meal speed accurately. Such obstacles make managing type 1 pediatric diabetes a challenge for both parents and patients.

As per statement from manufacturer Novo Nordisk “In the case of conventional fast-acting insulin, it was difficult to control blood glucose levels to a sufficient level because pediatric diabetics had to pre-measure the appropriate dose. Fisap is the first and only fast-acting meal insulin that can be administered two minutes before a meal or 20 minutes after starting the meal”.


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