FDA approves Fiasp (insulin aspart injection) for type 1 and type 2 diabetes.- Novo Nordisk.

Novo Nordisk announced that the FDA approved Fiasp (insulin aspart injection) 100 Units/mL, 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 and 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.

The approval of Fiasp is based on results from the onset phase IIIa 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, occuring in at least 5% of subjects included nasopharyngitis, upper respiratory tract infection, nausea, diarrhea and back pain.