FDA Extends Awiqli Weekly Basal Insulin Approval to Children 10 and Older

The FDA has approved insulin icodec-abae (Awiqli, Novo Nordisk) injection 700 units/mL as an adjunct to diet and exercise to improve glycemic control in children 10 years of age and older with type 2 diabetes, Novo Nordisk announced. The company described the product as the first once-weekly, long-acting basal insulin.

The approval extends to pediatric patients a basal insulin that is also indicated for adults with type 2 diabetes. According to the company, once-weekly dosing reduces basal insulin injections from 7 per week to 1. Awiqli is injected once weekly on the same day each week using the Awiqli FlexTouch pen. Its safety and effectiveness in children younger than 10 years are not known.

According to Novo Nordisk, the approval was supported by adequate and well-controlled studies in adults with type 2 diabetes and a single-dose pharmacokinetic study (NCT05790681) in pediatric patients aged 10 to younger than 18 years with type 2 diabetes, together with efficacy and safety data from the pivotal ONWARDS clinical trial program. That program evaluated the insulin in insulin-naive patients and in patients previously treated with insulin.

Serious risks listed in the company’s safety information include hypoglycemia, severe allergic reactions, hypokalemia, and heart failure when used with thiazolidinediones. Common adverse effects include hypoglycemia, injection site reactions, lipodystrophy, pruritus, rash, peripheral edema, and weight gain. The safety information also notes that Awiqli dosing differs from that of other injectable diabetes medicines, advises careful dose selection to avoid dosing errors and accidental overdose, and states that the insulin should not be withdrawn from the pen with a syringe.

Awiqli is available in a single U-700 concentration. Novo Nordisk said the insulin is approved in the US, the EU, and 18 additional countries, with market-specific indications.

Source: Novo Nordisk. Novo’s Awiqli receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes. Press release. Novo Nordisk; October 23, 2026. Accessed October 25, 2026.