FDA approves inhaled insulin Afrezza for children and adolescents with diabetes

The FDA has approved Afrezza (insulin human) Inhalation Powder for use in patients aged 6 years and older with diabetes, making it the first rapid-acting inhaled insulin available for pediatric patients requiring mealtime insulin.¹

The approval was supported by findings from the phase 3 INHALE-1 study, a 26-week open-label clinical trial that evaluated Afrezza compared with multiple daily injections (MDI) of rapid-acting insulin analogs in combination with basal insulin. Investigators enrolled 230 pediatric participants with type 1 or type 2 diabetes and randomly assigned them to receive either Afrezza or injectable rapid-acting insulin therapy.²

According to MannKind Corporation, the study met its primary endpoint in a modified intent-to-treat analysis, demonstrating noninferiority of Afrezza compared with MDI therapy for change in hemoglobin A1c (HbA1c) levels after 26 weeks of treatment.

Afrezza offers alternative to injections and insulin pumps

The approval provides pediatric patients with a new option for mealtime insulin delivery beyond injections and insulin pump therapy. Afrezza is designed to more closely replicate the body’s natural insulin response during meals by acting within minutes and clearing the body more rapidly than traditional injectable rapid-acting insulins. According to the company, the inhaled therapy may help reduce postmeal glucose elevations, improve treatment adherence, and decrease the daily management burden for children, adolescents, and their caregivers.

“I am very excited as a pediatric endocrinologist working with children and teens and their families for more than 30 years,” said Kevin Kaiserman, MD, senior vice president and therapeutic area head for diabetes at MannKind Corporation. “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.”

Kaiserman noted that the approval aligns with updated American Diabetes Association standards of care that emphasize shared decision-making between clinicians and patients regarding insulin delivery methods.³

“This really ties in with the recent updates to the American Diabetes Association standards of care, which talk about 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,” said Kaiserman.

Study shows comparable glycemic control and lung safety

Investigators also evaluated pulmonary safety outcomes because Afrezza is administered through oral inhalation. Lung function findings did not demonstrate clinically meaningful differences between treatment groups over the study period.

Among Afrezza-treated participants, mean forced expiratory volume in 1 second (FEV1) was 2.901 L at baseline, representing 99.6% of predicted lung function values, compared with 2.934 L at week 26, representing 96.6% of predicted values. Participants receiving MDI therapy had mean FEV1 values of 2.948 L at baseline and 2.957 L at 26 weeks, corresponding to 102.3% and 98% of predicted values, respectively.

Additional safety outcomes, including hypoglycemia rates, did not reveal significant differences between the treatment groups, according to the company.

Rapid onset may help children with unpredictable schedules

Kaiserman also highlighted the potential benefits of inhaled insulin for children and adolescents with unpredictable eating schedules and activity patterns.

“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.

He added that the rapid onset of inhaled insulin may help address challenges associated with premeal insulin timing.

“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.”

Boxed warning highlights pulmonary risks

Afrezza has previously been approved only for adults with diabetes mellitus.²

The product includes a boxed warning regarding the risk of acute bronchospasm in patients with chronic lung disease. Afrezza is contraindicated in patients with asthma or chronic obstructive pulmonary disease and is not recommended for individuals who smoke or who have recently stopped smoking. Before initiating therapy, clinicians should perform a medical history, physical examination, and spirometry testing to evaluate for underlying lung disease.

The most common adverse reactions associated with Afrezza include hypoglycemia, cough, and throat pain or irritation

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. MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza). MannKind Corporation. Press release. December 16, 2024. Accessed May 29, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-six-month-results-phase-3-inhale-1-pediatric
3. 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