Global healthcare company, Novo Nordisk, has revealed that the US Food and Drug Administration (FDA) has approved its fast-acting mealtime insulin, Fiasp, for the improvement of glycaemic control in adults with diabetes.
Insulin
Fiasp — insulin aspart injection — is a new formulation of NovoLog, featuring the addition of niacinamide (vitamin B3) to increase the absorption rate of insulin. It will be available as a pre-filled delivery device FlexTouch pen and a 10 mL vial.
“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.”
The approval has been based on the results of the onset phase IIIa clinical development programme, which enrolled more than 2,000 adults with type 1 and 2 diabetes. The study evaluated the efficacy and safety of Fiasp when administered both at mealtime and after starting a meal. It was found that the treatment reduced A1C in adults with type 1 and 2 diabetes.