FDA Approves Awiqli, the First Once-Weekly Insulin for Children 10 and Older With Type 2 Diabetes
PLAINSBORO, New Jersey — Novo Nordisk announced on October 23 that the U.S. Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL to improve glycemic control, as an adjunct to diet and exercise, in children 10 years of age and older with type 2 diabetes. Awiqli is the first once-weekly, long-acting basal insulin, and the approval extends its use from adults to pediatric patients, reducing basal insulin injections from seven times a week to one. The FDA also listed the approval in its drug news index the same day as the first once-weekly insulin for type 2 diabetes in pediatric patients.
Michael Radin, executive medical director at Novo, said individuals with type 2 diabetes and their families seek treatment options that may allow for more individualized care, and that reducing basal injections from seven to one per week may help patients find a routine that feels more manageable. Eda Cengiz, Professor of Pediatrics at the University of California, San Francisco, said children with type 2 diabetes face an aggressive disease trajectory and that an FDA-approved once-weekly basal insulin could provide new alternatives for pediatric care and help reduce administration barriers.
The company said the approval is supported by adequate and well-controlled studies in adults with type 2 diabetes and a single-dose pharmacokinetic study in pediatric patients aged 10 to under 18, together with the efficacy and safety demonstrated in the pivotal ONWARDS clinical trial program. Awiqli is given once a week, on the same day each week, using the FlexTouch pen, is available at more than 70,000 pharmacies nationwide, and is approved in the United States, the European Union and 18 additional countries.
The company also released safety information: common side effects may include hypoglycemia, serious allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain; the drug should not be used during an episode of hypoglycemia or by people allergic to it, and its safety and effectiveness in children under 10 have not been established. Citing a modeling study, the company said the number of people aged 19 and under with type 2 diabetes in the United States is estimated to reach nearly 84,000 by 2050.
Published by GSM · USA (original Chinese edition)
Photo: 图：胰岛素注射笔使用示意（资料图）。Wikimedia Commons，CC BY-SA 4.0。 / An insulin pen in use (file photo). Via Wikimedia Commons, CC BY-SA 4.0.
