FDA approves Novo Nordisk’s Fiasp, a fast-acting formulation of NovoLog, the company’s insulin offering.

The FDA has approved Novo Nordisk’s fast-acting mealtime inulin formulation Fiasp® (insulin aspart injection) to help improve glycemic control in adults with both type 1 and type 2 diabetes. Fiasp, explained the company, is a new formulation of NovoLog® that can be dosed at the beginning, or within 20 minutes, of a meal to help manage the disease.

People often have trouble maintaining their target A1C levels around mealtime and a fast responding insulin can help patients do better. According to Novo Nordisk, when combined with niacinamide (vitamin B3), which accelerates initial insulin absorption, the onset of its appearance in the blood can be reduced to approximately 2.5 minutes.

"With Fiasp,” said Bruce Bode, President of the Atlanta Diabetes Associates and Associate Professor at Emory University School of Medicine, “we've built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target. 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 of Fiasp was based on results from the onset Phase 3a clinical development program. More than 2,000 adults with type 1 and type 2 diabetes were enrolled in the program, which evaluated the efficacy of the treatment administered at mealtime and after patients began their meals.

The trial data showed that Fiasp reduced A1C in adults with either type 1 or 2 diabetes. The new formulation will launch at the same prices as its prominent insulin product NovoLog, and will be available at a discounted rate to those eligible for the company’s patient assistance programs.