Kevin Kaiserman, MD, discusses the impact of the first inhaled insulin approval for pediatrics

The FDA has approved Afrezza (insulin human; MannKind Corporation) Inhalation Powder for children aged 6 years and older with diabetes, marking the first rapid-acting inhaled insulin available for pediatric patients.¹

For Kevin Kaiserman, MD, senior vice president and therapeutic area head for diabetes at MannKind Corporation, the approval represents the culmination of years of work to bring an alternative insulin delivery option to children and adolescents living with diabetes.

“I am very excited as a pediatric endocrinologist working with children and teens and their families for more than 30 years,” Kaiserman told Contemporary Pediatrics. “I joined MannKind about 6 years ago, specifically to try to bring the option of inhaled insulin to the pediatric population. So I’m obviously very pleased that after FDA review, we now have that indication and that option for people.”

The approval is based on findings from the phase 3 INHALE-1 trial, which evaluated Afrezza against multiple daily injections (MDI) of rapid-acting insulin analogs in children and adolescents with type 1 or type 2 diabetes.

Shared decision-making central to treatment selection

Kaiserman emphasized that the approval arrives at a time when diabetes care is increasingly focused on individualized treatment decisions.

According to Kaiserman, recent updates to the American Diabetes Association Standards of Care encourage clinicians and patients to work together when determining how insulin should be delivered.

“This really ties in with the recent updates to the American Diabetes Association standards of care, which talks about that shared decision making between HCP and patient, and really give them the option of what is the best therapy for them, what is the best way for them to deliver insulin,” Kaiserman said. “Rather than a clinician making that decision for them, really having that shared decision making, and really discussing that optionality.”²

Until now, pediatric patients requiring rapid-acting mealtime insulin primarily relied on injections or insulin pump therapy. The approval of Afrezza adds a new administration route that may appeal to some families based on lifestyle, treatment preferences, and daily diabetes management needs.

Why inhaled insulin may fit pediatric patients

Kaiserman said children and adolescents often face challenges that differ from those of adults, particularly when it comes to meal timing and activity schedules.

“Children have unique needs. They have very erratic eating schedules, they have very erratic day-to-day schedules with their school activities and sports, and one of the nice things about inhaled insulin is the speed of action, the ability to really match that insulin immediately with their food intake or their activities,” Kaiserman said.

Afrezza is designed to more closely replicate the body's natural insulin response at mealtime. The inhaled insulin begins working within minutes and leaves the body more quickly than traditional injectable rapid-acting insulins. According to MannKind, these characteristics may help reduce postmeal glucose excursions, improve adherence, and lessen the treatment burden for children and their caregivers.

Kaiserman noted that premeal insulin dosing can be difficult for many pediatric patients, particularly when food intake is unpredictable.

“The ability to dose right with that first bite of food is one of the clear advantages of inhaled insulin,” Kaiserman said. “It’s really about being able to match that timing of your insulin with what you’re doing next.”

Clinical trial supports approval

The INHALE-1 study evaluated Afrezza over 26 weeks and compared outcomes with MDI therapy. In a modified intent-to-treat analysis, Afrezza met the study’s primary endpoint by demonstrating noninferior glycemic control based on changes in HbA1c levels.

Safety findings were also comparable between treatment groups. Investigators reported no clinically meaningful differences in lung function measures, including forced expiratory volume in 1 second (FEV1), during the study period. Rates of hypoglycemia were similarly comparable between groups.

What pediatricians should know

Afrezza is administered through a handheld inhaler at mealtimes and is indicated for use in children aged 6 years and older with diabetes who require rapid-acting insulin. The product includes a boxed warning regarding the risk of acute bronchospasm in patients with chronic lung disease and is contraindicated in patients with asthma or chronic obstructive pulmonary disease.

For pediatricians and pediatric endocrinologists, the approval provides a new option to discuss with families as part of individualized diabetes management plans. For Kaiserman, the significance of the approval centers on expanding choice.

With inhaled insulin now available to children aged 6 years and older, clinicians and families have an additional tool that may help align insulin delivery with the realities of childhood and adolescence while maintaining glycemic control.

Disclosure: Kaiserman is senior vice president and therapeutic area head for diabetes at MannKind Corporation

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 May 29, 2026. https://investors.mannkindcorp.com/press-releases

2. American Diabetes Association Professional Practice Committee for Diabetes* . 1. Improving Care and Promoting Health in Populations: Standards of Care in Diabetes-2026. Diabetes Care. 2026;49(Supplement_1):S13-S26. doi:10.2337/dc26-S001