Novo Nordisk Korea said that it has received approval from the Ministry of Food and Drug Safety for an additional indication for Fiasp, its ultrafast-acting insulin aspart injection, for treating children and adolescents.
The additional indication from the local drug agency came after similar updated indication in the EU and U.S., based on the ONSET 7 study, participated in by 777 patients -- children and adolescents with type-1 diabetes.
The trial showed that Fiasp showed comparable glycemic control compared to conventional fast-acting insulin, such as Novorapid, with no additional safety risks.
Fiasp 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, the company said.
“Diabetes is a chronic disease that requires lifelong management, and the number of Korean children and adolescents with diabetes is increasing every year,” the company said. “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, the company added. Such obstacles make managing type 1 pediatric diabetes a challenge for both parents and patients, it explained.
“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,” the company said. “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.”