FDA approves new insulin Fiasp® by Novo Nordisk

Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp^® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycaemia 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. Fiasp^® 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.² 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 their meals. The result of this has led to many people with diabetes not achieving their target A1C.

"With Fiasp^®, we’ve built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target," said Bruce Bode, MD FACE, President of Atlanta Diabetes Associates and associate professor at Emory University School of Medicine. "The intention of rapid acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management."

Fiasp^® will launch at the same list price as NovoLog^® and will be offered with a Savings Card programme for eligible patients with commercial insurance to reduce co-payment. 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 hypoglycaemia, occurring in ≥5% of subjects included nasopharyngitis, upper respiratory tract infection, nausea, diarrhoea and back pain.