What’s Happening?
In an exciting update for the type 1 diabetes (T1D) community, Afrezza—a rapid-acting, inhaled mealtime insulin—has been approved by the FDA for use in children and adolescents ages 6+ with T1D. This makes Afrezza the first and only inhaled mealtime insulin approved for use in the pediatric T1D population. Families and care teams will soon be able to access Afrezza for eligible children and adolescents (with a prescription).
How Did This Happen?
MannKind Corporation, the maker of Afrezza, announced that the FDA has approved an expanded label for Afrezza to include children and adolescents ages 6+ with T1D. Afrezza was first approved by the FDA in 2014 for use in adults with diabetes, and today’s decision extends that approval to the pediatric population for the first time.
Regulators at the FDA reviewed data from the INHALE-1 clinical trial, which evaluated the safety and efficacy of Afrezza in children and adolescents with T1D. The study supported the conclusion that Afrezza can be safely and effectively used as a rapid-acting mealtime insulin in this population.
Why Options Matter in Pediatric T1D
Diabetes care is never one-size-fits-all—and that’s especially true for children and adolescents. Some young people prefer to manage their condition with automated insulin delivery (AID) systems; others struggle with pumps, infusion sets, or pre-meal injections. Expanding the range of approved therapies means families and care teams can match the treatment to the child, not the other way around.
Afrezza is Addressing an Unmet Need
Pre-meal insulin dosing is one of the most common pain points in pediatric T1D management. Missed and delayed mealtime doses are a leading cause of elevated blood sugar levels in kids, and the burden of repeated daily injections can weigh heavily on young people and their families.
Now, having an inhaled rapid-acting insulin option opens the door to a different way of managing mealtime insulin. For children who struggle with insulin injections, the social burden of injecting insulin at school, or are unable or uninterested in using AID systems, an inhaled option could make a real difference in daily life.
Afrezza is not a replacement for basal (long-acting) insulin and is not appropriate for every child—but as one more tool in the toolkit, it gives families and clinicians more flexibility to design a regimen that fits the child in front of them.
What Happens Next?
MannKind is continuing to study Afrezza in pediatric T1D populations to gather additional long-term data on safety, efficacy, and real-world use. Families interested in whether Afrezza may be appropriate for their child should speak with their diabetes care team.
The Bottom Line
For the first time, kids with T1D have an inhaled rapid-acting mealtime insulin option. This is a meaningful expansion of the pediatric T1D toolkit—not a replacement for what already works, but one more option for the children and families for whom existing options fall short.
Breakthrough T1D thanks the FDA for recognizing the unmet need in pediatric T1D care and approving Afrezza for use in this population, and we are grateful to MannKind for their continued research and commitment to expanding options for children and adolescents living with T1D.
