FDA Approves Rapid-Acting Inhaled Insulin for Children

FRIDAY, June 12, 2026 (HealthDay News) — The U.S. Food and Drug Administration has approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 years and older who are living with type 1 or type 2 diabetes.

Afrezza delivers insulin through the lungs using MannKind”s proprietary Technosphere drug-delivery platform, which enables rapid absorption of insulin. Afrezza is taken when eating to closely mimic the body’s natural insulin response at mealtime. Afrezza is already approved for use in adults.

The approval was based on results from the phase 3 INHALE-1 study of pediatric patients, along with clinical efficacy and safety evidence of Technosphere inhaled insulin use across more than 20 years and thousands of patients.

“For more than a century, insulin therapy for children living with diabetes has largely meant multiple daily injections,” Michael Castagna, Pharm.D., the chief executive officer of MannKind, said in a statement. “Afrezza allows dosing at the moment of eating, without the need for premeal planning, making it a practical option for unplanned meals and snacks on the go.”

Expanded approval of Afrezza was granted to MannKind.

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