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.

Novo Nordisk's ultrafast-acting insulin aspart injection Fiasp

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.”

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