The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s once-weekly insulin Awiqli for people age 10 and older with type 2 diabetes, extending the treatment to children while using blood-level modeling to estimate its glucose-lowering effect.
Patients inject Awiqli under the skin once a week, alongside diet and exercise. The FDA said no once-weekly insulin had previously been approved for children with type 2 diabetes. The agency cleared the drug for adults with the condition on March 26, 2026.
Novo Nordisk says the 700 units-per-milliliter product can reduce basal insulin injections from seven each week to one. The company also says Awiqli is available at more than 70,000 U.S. pharmacies and that a less frequent schedule may fit some family routines. The pediatric study did not assess whether the schedule improves adherence.
In the FDA’s assessment, children absorbed the first dose faster than adults. Modeling indicated their blood levels become similar to adults’ after the first few doses, leading the agency to expect a similar glucose-lowering effect. Novo said the approval also drew on efficacy and safety evidence from adult studies.
A 2025 study in Pediatric Diabetes followed 18 insulin-treated participants ages 10 to under 18. Each received a single 5.6 units-per-kilogram dose, with blood samples collected over 35 days. Researchers recorded one level 1 hypoglycemia episode and six mild adverse events in two participants. The single-dose study did not assess long-term outcomes from ongoing treatment in children.
The FDA identifies low blood sugar as a common adverse reaction. It warns that severe hypoglycemia can cause seizures, loss of consciousness or life-threatening complications, and advises patients to check the product label and the dose displayed on the pen before each injection.
