FDA Approves Fiasp for Patients with Type 1, Type 2 Diabetes
The Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection; Novo Nordisk) 100 Units/mL to improve glycemic control in adults with type 1 (T1D) and type 2 diabetes (T2D). This rapid-acting human insulin analog can be dosed at the start of a meal or within 20 minutes after starting a meal.
Fiasp is formulated with niacinamide which helps increase the speed of the initial insulin absorption. A pharmacokinetics study of adult patients with type 1 diabetes showed that Fiasp appeared in the circulation in approximately 2.5 minutes after administration. The time to maximum insulin concentrations was achieved in roughly 63 minutes after administration.
The efficacy of Fiasp was evaluated in 3 randomized, active-controlled trials of 18 to 26 weeks duration (T1D: n=763; T2D: n=461). In T1D patients, mealtime Fiasp and postmeal Fiasp led to non-inferior glycemic control compared to mealtime NovoLog, both in combination with insulin detemir.
In T2D patients, mealtime Fiasp provided non-inferior glycemic control compared to mealtime NovoLog, both in combination with metformin. In addition, Fiasp in a basal-bolus regimen with metformin also provided statistically significant improvement in overall glycemic control compared to basal insulin therapy alone with metformin.
Fiasp will be available in a pre-filled (3mL) delivery device FlexTouch pen and a 10mL vial.
For more information visit NovoNordisk.com.