Research & Development
Novo Nordisk announces FDA approval for Fiasp to treat children with diabetes
7 January 2020 -

Healthcare company Novo Nordisk reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for Fiasp (insulin aspart injection) 100 u/ml for use as a new mealtime insulin option for children with diabetes.

Fiasp, which is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation, is administered at the beginning of a meal or within 20 minutes after starting a meal. It is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation, added the company.

According to the company, Fias 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.

This US FDA approval of Fiasp for paediatric use was based on data from the company's onset 7, a 26-week, phase 3b, partially double-blind, basal-bolus, treat-to-target trial, which investigated the efficacy and safety of Fiasp compared with conventional insulin aspart in 777 children with type 1 diabetes, one of the most common chronic conditions diagnosed in childhood, with nearly 18,000 new cases each year.

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