FDA expands label for Fiasp in type 1 and 2 diabetes.- Novo Nordisk

Novo Nordisk announced that the FDA has expanded the label for Fiasp (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes. Fiasp, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.

The label change is based on the FDA's review of data from the onset 5 clinical trial, which confirmed the efficacy and safety of Fiasp when used in insulin infusion pumps in adults with diabetes. Fiasp has been shown to be well-tolerated and effective in pumps releasing steady doses throughout the day and mealtime doses during meals. The pump should be programmed based on guidance from healthcare providers and the pump maker's instructions.