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Novo Nordisk Receives FDA Approval for Fiasp®, a New Fast-Acting Mealtime Insulin

Press release 

Plainsboro, N.J. (September 29, 2017) – Novo Nordisk today announced that the U.S. Food and Drug Administration (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. 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.

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. 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 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. Patients and caregivers can obtain more information and access to the Novo Nordisk Patient Assistance Program by calling toll free at 866-310-7549.

The entire release is here.