FDA OKs Faster Aspart Insulin for Children With Diabetes

Miriam E. Tucker

Disclosures

January 06, 2020

The US Food and Drug Administration (FDA) has approved the use of the faster-acting insulin aspart (Fiasp 100 units/mL, Novo Nordisk) for pediatric patients with diabetes.

Fiasp (aka "faster aspart"), a newer formulation of insulin aspart recombinant (NovoLog, Novo Nordisk) with niacinamide added to increase absorption speed, was first approved by the FDA in September 2017 for use by adults and in October 2019 for use in insulin pumps.

Faster aspart can be administered via multiple daily injections and insulin pumps and is approved for intravenous infusion under supervision by healthcare professionals.

In contrast to other rapid-acting insulins that are recommended to be taken prior to a meal, faster aspart is indicated for use at the beginning of a meal or within 20 minutes after starting a meal.

The approval is based on data from the 26-week onset 7 trial (Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes).

The double-blinded study randomly assigned children aged 1–18 years to receive either mealtime faster aspart (n = 260), insulin aspart (258), or post-meal open-label faster aspart (259).

Mealtime and post-meal faster aspart were noninferior to insulin aspart in the primary endpoint, which was change in hemoglobin A1c level from baseline (P < .001 for noninferiority), with a statistically significant improvement for mealtime faster aspart (P = .014). Postprandial glucose levels were also lower with faster aspart (P < .01). Hypoglycemia rates did not differ.

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