Afrezza’s Pediatric Approval and Improving Adolescent Diabetes Care

On May 29, 2026, the US Food and Drug Administration (FDA) announced its approval of Afrezza, MannKind’s inhaled insulin, for adolescent patients aged 6 years and older with type 1 diabetes (T1D) or type 2 diabetes (T2D).1

Optimal glycemic control among pediatric patients with diabetes is a consistent challenge, with many often missing or delaying meal or snack boluses. Additionally, >350,000 children and adolescents in the US currently live with diabetes, many of whom rely on lifelong insulin therapy. To discuss the impact this approval may have on the field of pediatric diabetes care, the editorial team at HCPLive spoke with Jamie Wood, MD, medical director of pediatric diabetes at UH Rainbow Babies and Children’s Hospital, and an investigator in the pivotal INHALE-1 trial of Afrezza in pediatric patients.1,2

“Youth with type 1 and type 2 diabetes still have a lot of unmet needs in their management, despite all of the advances that have already happened,” Wood told HCPLive. “A lot of these unmet needs are around psychosocial issues like distress and diabetes burden, as well as the challenges of daily management. Inhaled insulin, otherwise known as Afrezza, can help with a few of those barriers.”

Conducted across 38 endocrinology practices in the US for 26 weeks, INHALE-1 enrolled patients between the ages of 4 and 17 years. Other eligibility criteria included a clinical diagnosis of T1D for ≥6 months or T2D for ≥3 months treated with multiple daily injections (MDIs) of insulin for ≥2 weeks, as well as an HbA1c of 7-11%. Patients were excluded if they had received asthma treatment in the prior 12 months or had experienced diabetic ketoacidosis (DKA) or severe hypoglycemia in the prior 90 days, among other criteria.2

Patients were randomly assigned in a 1:1 ratio to receive either inhaled insulin or rapid-acting analog (RAA) insulin, plus continuation of long-acting basal insulin and continuous glucose monitoring (CGM) for 26 weeks. Additionally, investigators monitored binary HbA1c metrics and CGM metrics. Safety outcomes included severe hypoglycemia, DKA, and all adverse events.2

A total of 313 patients were initially screened for inclusion – of these, 230 were enrolled to either the inhaled insulin arm (n = 117) or the RAA arm (n = 113). Mean age across both groups (+/- standard deviation [SD]) was 12.6 +/- 3 years and mean HbA1c was 8.2% +/- 0.9%. T1D was present in 225 patients (98%) and T2D was present in 5 patients (2%).2

Ultimately, patients in the inhaled insulin arm displayed a mean HbA1c of 8.41 +/- 1.38 at 26 weeks, while those in the RAA arm had a mean HbA1c of 8.21 +/- 1.1 (adjusted difference = 0.18; 95% CI, -0.08 to 0.43; noninferiority P = .091). CGM-measured time in range was not substantially different between groups. The inhaled insulin group did, however, report greater treatment satisfaction and displayed less gain in weight than the RAA group.2

Despite failing to meet the prespecified criteria for HbA1c noninferiority, the trial did demonstrate inhaled insulin’s safety and associated it with greater treatment satisfaction and less weight gain compared with RAA. When taken in conjunction with additional safety data collected over 20 years of investigating Afrezza in adult and pediatric patients, these data were enough for the FDA to justify the approval.1,2

“Just because a trial ends does not mean the monitoring stops,” Wood said. “With FDA approval, we are still going to need to monitor and continue to evaluate for safety and efficacy in kids and adults. Ongoing monitoring is going to be the first priority.”

Editors’ Note: Wood reports no relevant disclosures.

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 June 1, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-afrezzar-first-and-only-inhaled

2. 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. 2026;49(1):179-187. doi:10.2337/dc25-1994