FDA approves Afrezza for children and adolescents with diabetes

The FDA has approved MannKind Corp.’s supplemental biologics license application (sBLA) for Afrezza (insulin human) Inhalation Powder for adolescents and children aged 6 and older who have Type 1 or Type 2 diabetes. This is the first needle-free insulin option for pediatric patients with diabetes.

In the United States, more than 350,000 children and adolescents are living with diabetes, the majority of whom have Type 1 diabetes and require lifelong insulin therapy.

“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary,” Desmond A. Schatz, M.D., professor of Pediatrics, University of Florida College of Medicine, said in a news release. “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.”

Afrezza is a rapid-acting insulin that was first approved by the FDA for adults (age 18+) in June 2014. It delivers insulin into the bloodstream through the lungs using MannKind’s proprietary Technosphere drug-delivery platform. Afrezza is supplied in single-use cartridges of 4, 8, or 12 units, and dosing is individualized based on glucose response.

The American Diabetes Association recommends clinicians consider Afrezza alongside multiple daily injections and insulin pumps.

Afrezza generated sales of $74.6 million in 2025, up 10.5% from 2024. Patients with Medicare or commercial insurance can access Afrezza for $35 a month or less. MannKind offers a direct purchase program for $99 a month.

The approval is based on data from the phase 3 INHALE-1 study in children and adolescents between the ages of 4 and 17 who are living with either Type 1 or Type 2 diabetes. The 26-week open-label trial evaluated Afrezza in combination with basal insulin compared with multiple daily injections with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks.

The study found that in a modified ITT (mITT) analysis, which excluded a patient who did not adhere to study protocols, Afrezza was found to be non-inferior to daily injections of insulin.

Over 26 weeks of treatment, there no difference in lung function between the treatment groups. Additionally, there were no differences in the groups for hypoglycemia, which is a complication of Type 1 diabetes where glucose levels become too low.

Data from INHALE-1 were released in December. 2024.

The submission also included safety data from the study’s 26-week extension phase in which all remaining patients receiving multiple daily injections switched to Afrezza.