FDA Approves Afrezza Insulin Inhalation Powder for Children, Adolescents With Type 1 and Type 2 Diabetes

The FDA approved insulin human (Afrezza; MannKind Corporation) inhalation powder for the management of type 1 and type 2 diabetes in children and adolescents 6 years and older. According to the news release announcing the approval, this expanded indication expands Afrezza’s availability beyond adults and introduces a new mealtime insulin option for pediatric patients and caregivers.¹

Afrezza is the only ultrarapid-acting inhaled insulin approved by the FDA to improve glycemic control in children, adolescents, and adult patients with type 1 and type 2 diabetes. It is administered at the beginning of meals using a small, portable inhaler, which delivers insulin via proprietary technology to enable ultrarapid absorption through the lungs. The agent has a fast onset of action and a short duration, more closely mirroring the body’s natural insulin response to meals.¹

Afrezza was first approved by the FDA in June 2014 to improve glycemic control in adult patients 18 years and older with diabetes, followed by an additional FDA approval for use in pediatric patients 6 years and older in May 2026.¹

“This approval is meaningful because it brings the first inhaled mealtime insulin option to children and adolescents 6 years and older with diabetes. For some families, especially those navigating injections around school, meals, sports, and social situations, Afrezza may reduce treatment burden and make prandial insulin delivery feel more flexible,” Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, professor of pharmacy practice and clinical pharmacist, Massachusetts College of Pharmacy and Health Sciences, said to Pharmacy Times.

What Supported the New Indication’s Approval?

The new indication’s approval is supported by clinical findings from the open-label, randomized phase 3 INHALE-1 clinical trial (NCT04974528), which randomly assigned 230 patients aged 4 to 17 years to Afrezza in combination with a basal insulin compared with insulin aspart, insulin lispro, or insulin glulisine in combination with a basal insulin. The change in hemoglobin A_1c (HbA_1c) levels at 26 weeks was assessed and compared between groups. After completing 26 weeks of randomly assigned treatment with either Afrezza or rapid-acting insulin injections combined with basal insulin, participants continued receiving the inhaled insulin until week 52 for an extension phase to evaluate the safety and effectiveness of Afrezza with continued use.^2,3

According to findings published in Diabetes Care, in intent-to-treat analysis, the mean HbA_1c was about 8.22 ± 0.87 at baseline and 8.41 ± 1.38 at 26 weeks with Afrezza and 8.21 ± 0.96 and 8.21 ± 1.10, rapid-acting analogue insulin, respectively (adjusted difference = 0.18 [95% CI, –0.07 to 0.43]; noninferiority P = .091). Additionally, continuous glucose monitor-measured time in range (70-180 mg/dL) was not significantly different between the groups (adjusted difference –2.2% [95% CI, –7.0 to 2.7]; P = .38).⁴

There were 2 severe hypoglycemic events that occurred in the Afrezza group and 1 in the comparator group. Change in forced expiration volume from baseline to 26 weeks did not differ (P = .53). The Afrezza group generally reported greater treatment satisfaction (P = .004) and had less gain in weight and body mass index percentile (P = .009) than did the comparator group.⁴

“[As a pharmacist,] I would view this less as a replacement for pumps, automated insulin delivery, or basal-bolus therapy, and more as an expansion of individualized options. The pediatric data suggest Afrezza may be most valuable for selected patients who prefer an inhaled mealtime insulin approach, with attention to appropriate pulmonary screening, glucose monitoring, and education,” Goldman said.

REFERENCES

1. 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. News release. MannKind Corporation. May 29, 2026. Accessed May 29, 2026. https://www.globenewswire.com/news-release/2026/05/29/3303734/29517/en/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.html 

2. Afrezza INHALE-1 study in pediatrics (INHALE-1). ClinicalTrials.gov. Updated May 6, 2025. Accessed May 29, 2026. https://clinicaltrials.gov/study/NCT04974528

3. Ferruggia K. Inhaled insulin demonstrates comparable safety, lung function, and efficacy to injectable insulin in type 1 diabetes. Pharmacy Times. October 13, 2025. Accessed May 29, 2026. https://www.pharmacytimes.com/view/inhaled-insulin-demonstrates-comparable-safety-lung-function-and-efficacy-to-injectable-insulin-in-type-1-diabetes

4. Haller MJ, Kanapka L, Monzavi R, et al; INHALE-1 Study Group. INHALE-1: a multicenter randomized trial of inhaled technosphere insulin in children with type 1 diabetes. Diabetes Care. 2026;49(1):179-187. doi:10.2337/dc25-1994