Novo Nordisk Korea got the Ministry of Food and Drug Safety’s approval for its ultrafast-acting insulin aspart injection Fiasp FlexTouch (insulin aspart) to treat diabetes patients, the company said Wednesday.
Fiasp is a new ultrafast-acting insulin drug that allows for safe, 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.
As a result, the injections produce a more endogenous insulin-like response. Pharmacokinetic (PK/PD) clinical results on insulin pumps also showed insulin exposure to be three times faster than conventional fast-acting insulin.
The approval was based on the results of phase 3 ONSET studies that evaluated the efficacy and safety of Fiasp on 689 patients with type 2 diabetes.
Results from the ONSET 2 study showed blood glucose control effect to be comparable to insulin aspart as well as a significant improvement in post-meal blood glucose.
The ONSET 1 study on 1,143 patients with type-1 diabetes showed a significant glycemic control effect compared to insulin aspart and a substantial reduction in post-meal blood glucose levels.
“We are pleased to be able to offer new treatment options to diabetics patients with the approval of Fiasp,” Novo Nordisk Korea CEO Rana Azfar Zafar said.
The therapy has won the go-ahead from the European Commission (EC) and more than 37 countries, including the United States, Canada, and the United Kingdom.
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