Novo Nordisk bags insulin aspart injection Fiasp FDA approval for diabetes
Fiasp FDA approval : Danish pharmaceutical company Novo Nordisk has secured the US FDA approval for its new fast-acting mealtime insulin aspart injection Fiasp 100 Units/mL for diabetes treatment in adults.
Already approved in Canada and Europe, Fiasp is the addition of two excipients to Novo Nordisk’s insulin aspart (NovoLog) in a new formulation with an objective to nearly mimics the physiological insulin response around mealtime of a non-diabetic person.
The two excipients which have been added to insulin aspart to deliver faster insulin action are Vitamin B3 (niacinamide) and L-Arginine. Niacinamide has been added to boost the absorption speed while L-Arginine is a naturally occurring amino acid used for stability.
Fiasp can be taken by diabetic patients at the start of a meal or inside 20 minutes after beginning a meal. Following the US approval of Fiasp, the mealtime insulin aspart will be available in FlexTouch pen which is a a pre-filled delivery device along with a 10 mL vial.
Novo Nordisk headquarters in Bagsværd, Denmark. Photo courtesy of Novo Nordisk A/S.
Commenting on Fiasp FDA approval, Novo Nordisk’s executive vice president and chief science officer Mads Krogsgaard Thomsen stated: “We are very pleased that Fiasp will now also be available to people with diabetes in the US.
“The fast action profile of Fiasp allows people with diabetes convenient timing in terms of when to take their insulin in connection with meals to achieve the optimal blood sugar control.”
Fiasp FDA Approval
Novo Nordisk insulin product Fiasp FDA approval was based on a phase 3 clinical program named ‘onset’ which was made of four trials having 2,100 patients suffering from type 1 and type 2 diabetes.
According to the Danish pharmaceutical company, FDA’s favorable decision on Fiasp insulin product comes after the mealtime insulin demonstrated benefits for people requiring improved control of overall glucose.
Fiasp mealtime insulin aspart injection had shown clinically relevant improvement in long-term glucose level (HbA1c) in clinical trials, stated the Danish pharmaceutical company in connection with the Fiasp FDA approval.