FDA Approves Mealtime Insulin Option for Pediatric Patients With Diabetes – Endocrinology Advisor

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The Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection; Novo Nordisk), a rapid-acting human insulin analog, for use in pediatric patients with diabetes mellitus.

The approval was based on data from an active-controlled, treat-to-target trial (Onset7) that included 777 pediatric patients (aged 2 to 17 years) with type 1 diabetes. Patients were randomized to either blinded mealtime Fiasp (injected 0 to 2 minutes before a meal; n=260), blinded mealtime NovoLog (injected 0 to 2 minutes before a meal; n=258), or open-label postmeal Fiasp (injected 20 minutes after the start of a meal; n=259), all in combination with once daily insulin degludec.

Findings showed that at Week 26, both mealtime and postmeal treatment with Fiasp resulted in effective glycemic control when compared with NovoLog. As for safety, hypoglycemia rates were found to be similar between the groups, however pediatric patients treated with Fiasp reported a higher rate of blood glucose confirmed hypoglycemic episodes, particularly during the nocturnal period.

Fiasp is available in multiple presentations including 10mL vials, 3mL FlexTouch pens, and 3mL PenFill cartridges for use in a PenFill cartridge delivery device. The treatment can be administered through subcutaneous injection, continuous subcutaneous infusion, or intravenous infusion.

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For more information visit novonordisk-us.com.

This article originally appeared on MPR

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FDA Approves Mealtime Insulin Option for Pediatric Patients With Diabetes - Endocrinology Advisor