The U.S. Food and Drug Administration (FDA) has accepted MannKind Corporation’s application to expand the use of Afrezza, the company’s inhaled insulin, to children and adolescents ages 4 to 17 living with type 1 or type 2 diabetes.

If approved, Afrezza would become the first inhaled mealtime insulin available for young people in the U.S., offering a potential alternative to injections or insulin pumps. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of May 29, 2026, when it will make its approval decision.

Afrezza is a rapid-acting insulin powder delivered through a small, breath-powered device that requires just a quick, two-second inhalation. First approved for adults in 2014, the treatment was designed to simplify mealtime insulin dosing without the use of needles or electronics. We spoke with an adult user of Afrezza on the Diabetech podcast about their experience using the inhaled insulin and how it fits into everyday diabetes care.

Safety monitoring is ongoing as regulators review the known adult safety profile for use in younger patients. The FDA’s review comes as innovation in insulin delivery continues to accelerate, with new formulations and delivery systems aiming to make treatment more flexible and less burdensome. We recently explored these emerging therapies and the evolving future of insulin development. Full pediatric study results are expected to be presented at the International Society for Pediatric and Adolescent Diabetes (ISPAD) Conference in November 2025, with a final decision anticipated by May 2026.

If approved, Afrezza could expand insulin options for children and teens, offering a faster insulin to manage blood sugar at mealtimes.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.