The recent FDA approval of Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 years and older has expanded treatment options for pediatric patients with diabetes.¹ At the American Diabetes Association (ADA) 2026 Scientific Sessions, MannKind Corporation presented new analyses that further explored the therapy's efficacy, safety, treatment satisfaction, and potential applications across a range of patient populations.²

Among the presentations were new findings from the phase 3 INHALE-1 study, including subgroup analyses in children and adolescents with type 1 diabetes and assessments of treatment satisfaction among patients who achieved glycemic targets. Additional data examined the use of inhaled insulin in gestational diabetes, integration with automated insulin delivery systems, and pharmacodynamic characteristics compared with rapid-acting insulin analogs.

In this Q&A, Kevin Kaiserman, MD, senior vice president and therapeutic area head of diabetes at MannKind, discusses the rationale behind the new analyses, key findings from the pediatric data, and how inhaled insulin may fit into individualized diabetes management strategies for children and adolescents.

Q&A

Contemporary Pediatrics: What was the rationale for conducting a subgroup analysis of youth with HbA1C in the INHALE-1 trial, and what key findings stood out when comparing inhaled technosphere insulin with rapid-acting analog insulin in this population?

Kevin Kaiserman, MD:

We're really looking at different ways of looking at the data, trying to understand the individuals who may have had the best outcomes in the trial, and what we can share with health care providers from key learnings from the study. The subgroup analysis looking at an A1c less than 9.5 is consistent with other registrational trials for mealtime insulin and the A1c cut-off that they used. So, trying to give some perspective and more of a comparison to other trials. But what we show is that when you take some of those people at the higher A1c who maybe are less engaged in their diabetes management, we see much more similar A1c outcomes between groups, and really showing that again, this is an option for care and finding the right tool for the right patient in their journey with diabetes management.

Contemporary Pediatrics: For pediatric endocrinologists considering inhaled insulin for children or adolescents with Type 1 diabetes, what do the efficacy findings suggest about glycemic control, time in range, or treatment satisfaction compared with standard rapid-acting analogs?

Kaiserman:

I think that with the FDA review and our primary analysis from the INHALE-1 study, we now have the option of this therapy for children and adolescents living with diabetes, showing that this is a similar efficacy, similar safety, but also other key findings that may be beneficial, including timing of the meal relative to the insulin, being able to take your dose immediately prior to eating. We did not use carbohydrate counting as part of our trials. It's really more of a small-medium-large concept. So, again, trying to simplify insulin use for these patients. Some other benefits you talked about there were greater treatment satisfaction, both from parents of younger children as well as the teens themselves, self-reporting better treatment satisfaction using inhaled insulin relative to subcutaneous insulin. Another finding is that we saw less weight gain with inhaled insulin relative to the subcutaneous insulin. So, again, it's about finding the right tool for the right patient in their journey, and we're very pleased to have the option of inhaled insulin for children and adolescents living with diabetes.

Contemporary Pediatrics: What did the study reveal about pulmonary safety, hypoglycemia, or other adverse events associated with technosphere insulin in youth?

Kaiserman:

I was very pleased to see the results from the pediatric trial, which showed no difference in the pulmonary function testing between patients using inhaled insulin and those that were using subcutaneous insulin. So, that was a very important question going into the trial, certainly an important question for the regulatory review, and very pleased to say that there was absolutely no difference in the pulmonary function testing between groups. There was also no difference in the CGM-measured hypoglycemia between groups as well. So, no new safety signals at all in the pediatric trial relative to what's been previously reported in adults. The most common adverse event that's reported is a mild cough that is typically transient, goes down over time as people sort of get used to the therapy, and can also be mitigated with something like a sip of water before the dose as well. So, very pleased to see that while that is already a known adverse event related to inhaled insulin from our adult trials. The incidence of reported cough was less in kids, and we're talking about approximately 1 out of 5 kids reported cough, meaning that about 80% did not report cough.

Contemporary Pediatrics: Based on the INHALE-1 data, which pediatric patients may be the best candidates for inhaled insulin, and how could this therapy fit into current diabetes management strategies for children and adolescents?

Kaiserman:

I like to think that this could be an option for any patient, and I think that it should be discussed with all patients. But if you talk about specific individuals that may do better, we were very pleased to see that those patients who were teenagers, sort of middle and high school age students, had better outcomes with the therapy, and that having that control, that freedom to sort of make their choices seemed to work well. That's traditionally a very difficult group to treat in pediatric diabetes. Certainly, a very small number of patients are getting to the glycemic targets in this age range; approximately 80% plus are not achieving their glycemic goals. So, trying to find different tools to find the right fit for that individual. So, middle and high school age students, certainly those who are struggling with the timing of their dosing, because again, the value of this therapy is the ability to dose right when you start eating, as opposed to subcutaneous insulins, which you generally are supposed to dose before eating, and then people with active lifestyles. So, whether you know extracurricular activities, sports, different eating, erratic eating schedules, those are all things that may benefit from the option of inhaled insulin.

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. Press release. May 29, 2026. Accessed June 11, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-afrezzar-first-and-only-inhaled

2. Mannkind Corporation. Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of MannKind’s Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and Use with Automated Insulin Delivery (AID) Systems. Mannkind Corporation. Press release. June 5, 2026. Accessed June 11, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/data-ada-2026-highlights-key-findings-clinical-and-real-world