FDA Approves MannKind's Afrezza as First Inhaled Mealtime Insulin for Children, Supported by Key ADA 2026 Data

FDA Approves MannKind's Afrezza as First Inhaled Mealtime Insulin for Children, Supported by Key ADA 2026 Data

On May 29, 2026, the U.S. Food and Drug Administration (FDA) approved MannKind Corporation's Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 years and older living with type 1 or type 2 diabetes. This landmark approval marks the first and only ultra-rapid-acting inhaled mealtime insulin available to pediatric patients, offering a needle-free alternative to multiple daily injections (MDI) or continuous pump infusions.¹

Shortly after the approval, detailed clinical findings and patient-reported outcomes from the pivotal Phase 3 INHALE-1 trial (NCT04974528) were presented at the American Diabetes Association (ADA) 2026 Scientific Sessions in New Orleans (June 5-8, 2026), providing strong clinical validation for the pediatric rollout.

Pivotal Phase 3 INHALE-1 Trial Design and Efficacy

The INHALE-1 trial was a multicenter, randomized controlled trial that enrolled 230 children and adolescents (aged 4 to 17 years) over a 26-week period, comparing inhaled insulin (plus injected basal insulin) against multiple daily injections of rapid-acting insulin analogs (RAA) plus basal insulin:

• Glycemic Noninferiority: In the primary intention-to-treat (ITT) analysis, the mean HbA1c in the inhaled insulin group was slightly higher than the injection group, which did not technically meet the strict predefined noninferiority margin. However, a prespecified sensitivity analysis excluding a single participant who failed to use the inhaled insulin as directed successfully established clinical noninferiority.
• Continuous Glucose Monitoring (CGM) Metrics: Crucial real-world glycemic metrics—such as Time in Range (TIR), time below range (hypoglycemia), and time above range (hyperglycemia)—were virtually identical between the inhaled insulin and RAA injection groups.
• Postprandial Excursions: Inhaled insulin demonstrated nominally reduced postprandial glucose spikes following meals compared to injected RAA.

Reassuring Pulmonary and Safety Outcomes

Because Afrezza is inhaled into the lungs, establishing pulmonary safety in a pediatric population was paramount.

• Pulmonary Function: Investigators monitored forced expiratory volume in 1 second (FEV1) at baseline and every 3 months. The trial demonstrated no statistically significant differences in pulmonary function between the inhaled and injected insulin cohorts over the 26-week period.
• Hypoglycemia & DKA: Rates of severe hypoglycemia and diabetic ketoacidosis (DKA) were similar between both treatment arms.
• Weight Control: Pediatric participants randomized to the inhaled insulin arm experienced less weight gain than those on traditional injections.

Clinical Advantages: "Fast On, Fast Off" Pharmacokinetics

A major clinical advantage of Afrezza is its ultra-rapid pharmacokinetic profile. The insulin enters the bloodstream within minutes, peaks in 35 to 50 minutes, and is largely cleared from the body within 90 minutes.

This rapid clearance is highly beneficial for active children and adolescents. Principal investigator Dr. Jamie Wood, MD, pediatric endocrinologist and medical director of pediatric diabetes at UH Rainbow Babies & Children’s Hospital, highlighted a case of a high school football player who frequently suffered from hypoglycemia during practice due to lingering injected mealtime insulin. After switching to Afrezza, the rapid clearance prevented active insulin from overlapping with his physical training, resolving his exercise-induced hypoglycemic episodes.

Dr. Wood emphasized that this approval expands patient-reported satisfaction and treatment choices:

"Children with diabetes have more choices, and they have more options in how they choose to manage their diabetes... The pediatric patients and their parents reported improved satisfaction with their treatment when they were on inhaled insulin."

Dr. Desmond Schatz, Professor of Pediatrics at the University of Florida College of Medicine, added:

"Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary. 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."