Novo Nordisk wins FDA nod for fast-acting mealtime insulin

Novo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection.

The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported.

The company’s Fiasp product is a redesigned formulation of its NovoLog product, with added vitamin B3 to boost initial insulin absorption and trigger an onset of appearance in the blood in 2.5 minutes.

Novo Nordisk said it plans to offer Fiasp in a pre-filled delivery device, FlexTouch pen, and a 10 milliliter 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,” Dr. Bruce Bode, president of Atlanta Diabetes Associates & an associate professor at Emory University School of Medicine, said in prepared remarks.

“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’s approval was supported by a Phase IIIa clinical development program, involving more than 2,000 people with Type I and Type II diabetes.