Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes. Fiasp is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp is now available for use in children and adults in three different dosing options: multiple daily injections (MDI), continuous subcutaneous insulin infusion pumps and intravenous infusion under supervision by a healthcare professional.
Diabetes is one of the most common chronic conditions diagnosed in childhood, with nearly 18,000 new cases of type 1 diabetes each year. Managing diabetes can be challenging for parents and caregivers given it is hard to know exactly how much or how quickly their 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 living with diabetes may not achieve adequate blood sugar control.
“As a parent of a son living with type 1 diabetes, I know first-hand how tough it can be to address the inevitable blood sugar spikes around mealtimes,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “Children can be unpredictable and having the option of a fast-acting insulin that doesn’t require pre-meal dosing like Fiasp is a welcome development for the diabetes community.”
The approval is based on the FDA’s review of data from the onset 7 clinical trial, which confirmed the efficacy and safety of Fiasp in children.