US FDA approves first weekly insulin for children with diabetes

The U.S. Food and Drug Administration (FDA) has approved the use of the first long-acting insulin that is injected once weekly for children with type 2 diabetes, a step aimed at reducing the number of injections required by young patients. The drug, named “Awiqli,” contains the active ingredient “insulin icodec” and is produced by the Danish company Novo Nordisk. Its use is permitted for children aged 10 and older, in conjunction with diet and physical activity, to help control blood sugar levels. The new treatment reduces the number of baseline insulin injections from seven times a week to just once a week, compared with conventional therapies that require daily injections, potentially easing adherence to the treatment plan and giving children and their families greater flexibility in managing the disease. The approval was based on clinical trial results conducted in adults, as well as a study examining the pharmacokinetic properties of insulin in 18 children and adolescents aged 10 to 17, which showed that its effect lasts throughout the weekly dosing interval. The U.S. agency warned that the drug may cause side effects, most notably hypoglycemia, allergic reactions, injection site reactions, and weight gain, emphasizing the importance of adhering to prescribed doses and monitoring blood sugar levels to avoid complications. This approval does not extend to children with type 1 diabetes, and the safety and efficacy of the drug have not been established in children under the age of 10.