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FDA Approves Fiasp for Children With Diabetes

Fast-acting insulin aspart may simplify mealtime dosing

The FDA has approved insulin aspart injection (Fiasp, Novo Nordisk), 100 U/mL, as a new mealtime option for children with diabetes—the first fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.

Diabetes is one of the most common chronic conditions of childhood, with nearly 18,000 new cases of type-1 diabetes diagnosed each year. Managing diabetes can be challenging for parents and caregivers because it is hard to know exactly how much or how quickly children will eat, making mealtime insulin dosing difficult. Conventional rapid-acting insulins must be administered ahead of meals, which requires some guesswork to dose properly, and children with diabetes may not achieve adequate blood sugar control.

Fiasp is administered at the beginning of a meal or within 20 minutes after starting a meal.

The approval of Fiasp for pediatric use was based on data from onset 7, a 26-week, phase 3b, partially double-blind, basal-bolus, treat-to-target trial. The study confirmed the efficacy and safety of Fiasp compared with conventional insulin aspart in 777 children with type-1 diabetes.

Fiasp is available for children and adults in three dosing options: multiple daily injections, continuous subcutaneous insulin infusion pumps, and intravenous infusion under supervision by a health care professional.

Information about cost and savings offers, including co-pay and patient assistance programs, is available at

Source: Novo Nordisk, January 6, 2020

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