Fiasp, a Fast-Acting Mealtime Insulin, Receives FDA Approval

Novo Nordisk modifies NovoLog with niacinamide

A new formulation of insulin aspart injection (Fiasp, Novo Nordisk) has received FDA approval. Fiasp 100 units/mL is a fast-acting mealtime insulin indicated to improve glycemic control in adults with type-1 and type-2 diabetes.

Fiasp can be dosed at the beginning of a meal or within 20 minutes after starting a meal. It is a new formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes. Fiasp will be available in a pre-filled delivery device (FlexTouch pen) and a 10-mL vial.

Many adults with type-1 and type-2 diabetes struggle with blood sugar control after meals. As a result, many people with diabetes do not achieve their target A1C.

Fiasp will launch at the same list price as NovoLog and will be offered with a savings card program for eligible patients with commercial insurance to reduce co-pays. Fiasp will also be available to eligible patients through the Novo Nordisk Patient Assistance Program.

The approval of Fiasp is based on results from the onset phase 3a clinical development program. The clinical trials enrolled more than 2,000 adults with type-1 and type-2 diabetes to evaluate the efficacy and safety of Fiasp administered both at mealtime and after starting a meal.

Data from the trials showed that Fiasp demonstrated a reduction in A1C in adults with type-1 and type-2 diabetes. Common adverse reactions, excluding hypoglycemia, occurring in 5% or more of subjects included nasopharyngitis, upper respiratory tract infection, nausea, diarrhea, and back pain.

Source: Novo Nordisk; September 29, 2017.