Jamie Wood, MD, on the significance of the Afrezza approval for pediatric diabetes

The FDA has approved Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 years and older with type 1 or type 2 diabetes, making the ultra-rapid-acting inhaled insulin available to pediatric patients for the first time.¹

For Jamie Wood, MD, pediatric endocrinologist and medical director of pediatric diabetes at UH Rainbow Babies & Children’s Hospital, the approval represents an expansion of treatment choices rather than a replacement for existing therapies.

“Children with diabetes have more choices, and they have more options in how they choose to manage their diabetes,” Wood said during an interview discussing the pivotal INHALE-1 clinical trial that supported the approval. “People living with diabetes deserve options, and working with their healthcare team to figure out which is the best option for them.”²

Afrezza joins multiple daily injection therapy and automated insulin delivery systems as another option for mealtime insulin administration. Wood noted that many pediatric patients will continue to choose insulin pumps, while others may prefer injections or inhaled insulin depending on their individual circumstances.

INHALE-1 evaluated efficacy and safety in pediatric patients

Wood served as one of the principal investigators for INHALE-1, a randomized controlled trial that enrolled 230 participants younger than 18 years. Participants were assigned to receive inhaled insulin plus injected basal insulin or to continue multiple daily injections with basal insulin for 26 weeks. Afterward, participants initially assigned to injections were allowed to switch to inhaled insulin for an additional 26 weeks.

The primary endpoint was hemoglobin A1c at 26 weeks.

According to Wood, the intention-to-treat analysis did not meet the trial’s predefined noninferiority benchmark because A1c levels in the inhaled insulin group were statistically, though not clinically, higher than those in the injection group.

However, a prespecified sensitivity analysis excluding a participant who did not use inhaled insulin as directed demonstrated noninferiority. Additional continuous glucose monitoring metrics, including time in range, time below range, and time above range, were similar between groups.

Wood highlighted patient-reported outcomes as an important finding.

“The pediatric patients and their parents reported improved satisfaction with their treatment when they were on inhaled insulin,” he said.

Investigators also observed less weight gain among participants receiving inhaled insulin.

Pulmonary safety findings provide reassurance

Because Afrezza had previously been approved only for adults, establishing safety in children was a key objective.

“We have a saying in pediatrics that children are not small adults,” Wood said.

Investigators monitored pulmonary function throughout the study using forced expiratory volume in 1 second (FEV1). Measurements obtained at baseline and every 3 months showed no statistically significant differences between the inhaled insulin and injection groups. Rates of severe hypoglycemia and diabetic ketoacidosis were also similar.

Potential advantages for adolescents and active patients

One finding that stood out to Wood involved older participants.

When investigators examined subgroup analyses, adolescents older than 13 years appeared to experience greater benefit than younger children. Wood suggested that the discretion and flexibility associated with inhaled insulin may have contributed to that observation.

He also described the product as “fast on and fast off,” noting that insulin reaches the bloodstream within minutes, peaks within approximately 35 to 50 minutes, and is largely cleared within about 90 minutes.

Those pharmacokinetic characteristics may be particularly beneficial for meals, sports, and activities. Wood described one trial participant, a football player who experienced hypoglycemia during practice after receiving injected mealtime insulin. After switching to inhaled insulin, the participant experienced fewer low blood glucose episodes because the insulin had largely cleared before practice began.

The approval was welcomed by diabetes advocates and clinicians.

“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary,” said Desmond Schatz, Professor of Pediatrics, University of Florida College of Medicine. “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.”

Wood said discussions about inhaled insulin should now become part of routine conversations with eligible pediatric patients and families, particularly for those with needle phobia, challenges related to exercise, or preferences that make injections or pump therapy less appealing.

Disclosure: Wood was a principal investigator on the INHALE-1 trial.

References

1. MannKind Corporation. 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. MannKind Corporation. May 29, 2026. Accessed June 2, 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