Fiasp Indication Expanded to Include Pediatric Patients

December 26, 2019 – The U.S. FDA has approved an expanded indication for Fiasp® (insulin aspart injection), manufactured by Novo Nordisk. Originally approved in 2017 to improve glycemic control in adults who have diabetes mellitus, the product is now also approved to treat pediatric patients.

Diabetes affects more than 30 million people in the United States. The disease occurs when the body is unable to produce enough insulin or cannot properly use the insulin that it does produce. In most cases, patients have either type 1 or type 2 diabetes, though there is another form – gestational diabetes – that can develop in women as a complication of pregnancy. When the body cannot use the insulin it produces or can’t make enough insulin, this can lead to high blood sugar (hyperglycemia). While some patients can control high blood sugar with diet, exercise, and medications other than insulin, others cannot.

In a clinical trial, Fiasp was compared to NovoLog® (insulin aspart – Novo Nordisk), an insulin product already approved for use in pediatric populations to improve glycemic control. While both products contain insulin aspart, Fiasp is a faster-acting formulation due to the addition of vitamin B3. During the clinical trial, Fiasp and NovoLog demonstrated similar safety and efficacy in children and adolescents who had type 1 diabetes.

Fiasp’s recommended dosing is based on individual patient factors such as age and metabolic needs, as well as the route of administration. Fiasp can be administered via subcutaneous injection, continuous subcutaneous infusion with an insulin pump, or intravenous infusion. It is available in 10mL multiple-dose vials, 3mL single-patient-use FlexTouch® pens, and in 3mL single-patient-use PenFill® cartridges for use in a PenFill cartridge device.