FDA/CDC

Fast-acting, mealtime insulin aspart is approved for kids


 

The Food and Drug Administration has approved a 100 U/mL fast-acting insulin aspart injection (Fiasp) as a new mealtime insulin option for children with type 1 diabetes, making it the first fast-acting mealtime insulin injection that does not come with a premeal dosing recommendation, according to a release.

A stamp saying "FDA approved." Olivier Le Moal/Getty Images

The injection is now available in various dosing options for both adult and pediatric patients with diabetes. Fast-acting mealtime insulin was approved in September 2017 for adults with type 1 or 2 disease, and in October 2019, it was approved for use in insulin pumps for adults.

The most recent approval was based on findings from the onset 7 trial, a 26-week, phase 3b, partially double-blind, treat-to-target trial that included 777 patients aged 1-18 years and demonstrated noninferiority to ordinary, non–fast-acting insulin aspart (Diabetes Care. 2019 Jul;42[7]:1255-62).

Removal of the premeal dosing requirement could help better manage mealtime insulin needs in children, according to the release from Novo Nordisk.

Use of the mealtime insulin injection comes with concerns of serious side effects, such as hypoglycemia, hypokalemia, serious allergic reactions, and heart failure. Common side effects can include skin problems (such as rash, itching, and swelling), injection-site reactions, and weight gain.

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