FDA Approves Inhaled Insulin Afrezza for Pediatric Patients With Diabetes

Announced by parent company MannKind Therapeutics on May 29, 2026, the US Food and Drug Administration (FDA) has officially approved inhaled insulin Afrezza for pediatric patients with either type 1 diabetes (T1D) or type 2 diabetes (T2D).1

“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary,” Desmond Schatz, professor of pediatrics at the University of Florida College of Medicine, said in a statement. “With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option.”1

Afrezza is the first and only ultra-rapid-acting inhaled insulin approved to improve glycemic control in adult patients with diabetes mellitus. The insulin is administered at the start of meals via a portable inhaler and utilizes MannKind’s proprietary Technosphere technology, which allows for rapid absorption in the lungs.2

Afrezza first received FDA approval in June 2014, allowing its use in adult patients with diabetes mellitus. In January of 2026, the FDA approved an update to Afrezza’s label, providing clinicians with starting dose guidance when switching from an insulin pump or daily injection insulin therapy.2,3

The FDA’s present decision is based in large part on data from the Phase 3 INHALE-1 study, which enrolled children and adolescents between 4 and 17 years with either T1D or T2D mellitus. INHALE-1 was an open-label, randomized clinical trial, evaluating Afrezza in combination with basal insulin compared to multiple daily injections (MDI) of basal insulin. The trial ran for 26 weeks and enrolled a total of 230 patients, of whom 98% had T1D and 2% had T2D. The trial’s primary outcome was change in HbA1c tested for noninferiority.4

Patients were eligible for enrollment if they had a diagnosis of T1D for ≥6 months or T2D for ≥3 months and had received multiple daily injections of insulin for ≥2 weeks. Additionally, patients were required to have an HbA1c of 7-11%. Patients with asthma treatment in the prior 12 months, diabetic ketoacidosis, or severe hypoglycemia in the prior 90 days were excluded.4

Eligible patients were then randomly assigned in a 1:1 ratio to either the Afrezza treatment group or the standard MDI group. At baseline, mean HbA1c (+/- standard deviation [SD]) was 8.22 +/- 0.87 in the Afrezza arm and 8.21 +/- 0.96 in the MDI arm. By 26 weeks, patients in the Afrezza arm displayed a mean HbA1c of 8.4 +/- 1.4, compared to 8.2 +/- 1.1 in the MDI arm (adjusted difference, 0.18%; 95% CI, -0.07 to 0.43; P = 0.091).4

Despite failing to achieve its primary endpoint, INHALE-1 successfully proved the safety of Afrezza in pediatric patients, showing no effect on pulmonary function. Additionally, although the intent-to-treat analysis did not show noninferiority to MDI insulin, it was deemed noninferior in the prespecified per-protocol analysis and in a post hoc sensitivity analysis.4

“For families raising children with diabetes, every day is shaped by treatment decisions — and those decisions are deeply personal,” Jeff Hitchcock, founder, president, and CEO of Children With Diabetes, said in a statement. “Having navigated those choices firsthand with my own child, I understand that what works for one child may not work for another, and parents know this better than anyone. The approval of Afrezza for pediatric use represents a meaningful step forward for children and adolescents living with diabetes, and for the families who support, advocate, and care for them every single day.”1

References

1. MannKind. MannKind Announces FDA Approval of Afrezza, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes. May 29, 2026. Accessed May 29, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-afrezzar-first-and-only-inhaled

2. MannKind Therapeutics. MannKind Announces US FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes. October 13, 2025. Accessed May 28, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental

3. MannKind Therapeutics. MannKind Announces FDA Approval of Updated Afrezza Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy. January 26, 2026. Accessed May 28, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-updated-afrezzar-label-providing

4. Haller MJ, Kanapka L, Monzavi R, et al. Inhale-1: A multicenter randomized trial of inhaled technosphere insulin in children with type 1 diabetes. Diabetes Care. 2025;49(1):179-187. doi:10.2337/dc25-1994