FDA Approves Fast-Acting Mealtime Insulin

Last week, Novo Nordisk announced that the FDA approved Fiasp (insulin apart injection) for adult patients with type 1 and type 2 diabetes. This fast-acting mealtime insulin can be taken at the beginning of a meal or within 20 minutes of starting a meal to prevent increases in A1C, according to a press release.

Fiasp is a combination of Novolog plus niacinamide, which increases the rate of insulin absorption. This formulation results in the appearance of insulin in the blood within 2.5 minutes, Novo Nordisk reported.

Many patients with diabetes fail to maintain glycemic control after meals. Novo Nordisk reported that this occurrence results in many patients not achieving target A1C levels, making mealtime insulin an important aspect of treatment.

The approval of Fiasp is based on findings from phase 3 clinical trials, which enrolled more than 2000 adults with type 1 and type 2 diabetes. The studies evaluated the safety and efficacy of the drug at mealtime and after starting a meal. The investigators found that Fiasp reduced A1C levels among these patients.

Common adverse events include nasopharyngitis, upper respiratory tract infection, nausea, diarrhea, and back pain, according to the release.

The drug will be sold in a pre-filled FlexTouch pen and a 10-mL vial at the same price as NovoLong, according to Novo Nordisk. The manufacturer will also offer a savings card to reduce co-payments for patients.

"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."