The FDA has approved Novo Nordisk’s Awiqli as the first once-weekly, long-acting basal insulin for children 10 years and older with Type 2 diabetes.
Awiqli (insulin icodec-abae) injection, 700 units/milliliter, was approved as an adjunct to diet and exercise to improve glycemic control, according to an Oct. 23 news release from Novo Nordisk. The treatment reduces basal insulin injection frequency from seven times per week to one.
The approval was supported by evidence from studies in adults with Type 2 diabetes and a single-dose pharmacokinetic study in pediatric patients ages 10 to 17. Efficacy and safety were also demonstrated in the ONWARDS clinical trial program.
Awiqli is available at more than 70,000 pharmacies nationwide.
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