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The FDA has approved the inhaled human insulin Afrezza (MannKind) for children aged 6 years or older with type 1 diabetes (T1D) or type 2 diabetes (T2D).

The product comprises a small inhaler device that delivers the insulin formulation into the bloodstream through the lungs, enabling rapid absorption into the systemic circulation with a short duration. The drug delivery platform, called Technosphere, is designed to be used immediately prior to meals. It does not replace basal insulin for people with T1D.

“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary,” said Desmond Schatz, professor of pediatrics, University of Florida College of Medicine, Gainesville, Florida, in a MannKind statement.

“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,” Schatz added.

The FDA first approved Afrezza for adults with diabetes in 2014. The new pediatric approval was based in part on data from the INHALE-1 clinical trial involving 230 youth aged 4-17 years with T1D (98%) or T2D (2%) randomly assigned to inhaled insulin or injected pre-meal insulin, all with continuation of basal insulin, for 26 weeks.

In the intent-to-treat analysis, mean A1c was 8.22% at baseline and 8.41% at 26 weeks with inhaled insulin vs 8.21% at both timepoints for injected rapid-acting analog insulin (P = .091). The difference did not meet the prespecified margin of 0.4% for noninferiority.

However, there were no major safety issues or changes in pulmonary function, and inhaled insulin was associated with greater treatment satisfaction and less weight gain than injected pre-meal insulin.

Inhaled insulin should not be used in people with chronic lung problems, including asthma or chronic obstructive pulmonary disease.

Afrezza is available for eligible patients for $35 or less per month, through MannKind Cares.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.