Novo Nordisk recently announced that the US Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL, the first once-weekly, long-acting basal insulin, as an adjunct to diet and exercise to improve glycemic control (blood sugar) in children 10 years of age and older with Type 2 Diabetes (T2D). This approval offers a once-weekly basal insulin treatment option, which reduces the frequency of weekly basal injections from 7 to 1 per week.

Michael Radin, MD, Executive Medical Director, Novo, said, "Individuals with Type 2 Diabetes and their families seek treatment options that may allow for more individualised care. Awiqli reduces basal insulin injections from 7 to 1 per week, which may help patients find a basal insulin routine that feels more manageable. It is important to continue to discover advanced treatments for the populations that need them today."

T2D in children and adolescents is a growing public health challenge, as more young people are being diagnosed each year with this chronic disease that requires ongoing care and caregiver support.

According to a modeling study, it's anticipated that the number of people ≤19 years old with T2D is estimated to reach nearly 84,000 by 2050. Healthy nutrition, physical activity, and family support are important aspects of care for T2D. However, for some young people, these measures may not be enough, potentially leading to complications related to this disease.

Novo's approach to pediatric care emphasises a comprehensive model of support–promoting healthy nutrition, regular physical activity, and diabetes education, alongside proven, age-appropriate treatment options for children and adolescents living with T2D.

This approval is supported by evidence from adequate and well-controlled studies in adults withT2D mellitus and a single-dose pharmacokinetic study completed in pediatric patients that evaluated the pharmacokinetic properties of once-weekly Awiqli injection in pediatric patients (10 to <18 years of age) with T2D. These results support the use of Awiqli in pediatric patients (at least 10 years of age and older), along with the efficacy and safety demonstrated in the pivotal ONWARDS clinical trial program.

Common side effects of Awiqli may include: hypoglycemia (low blood sugar), serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.

Eda Cengiz, MD, MHS, Professor of Pediatrics, University of California, San Francisco, said, "Children with Type 2 Diabetes face an aggressive disease trajectory and achieving sustained glycemic control in children with Type 2 Diabetes remains a major challenge. We need treatments that are not only effective but options that work for different patient routines. Having alternative options available for basal insulin therapy allows patients to find a treatment that works best for them and their lifestyle and helps them manage their Type 2 Diabetes. For more than 20 years, daily basal insulin injections have been a main form of treatment in pediatric diabetes care, but children living with Type 2 Diabetes may face challenges staying on a daily treatment routine. Having an FDA-approved, once-weekly basal insulin injection available could provide new alternatives for pediatric clinical care. Offering a once-weekly basal insulin may help reduce administration barriers associated with daily insulin injections and provide clinicians and families access to more individualised care."

Awiqli is available at more than 70,000 pharmacies nationwide.