First FDA-Approved Inhaled Insulin for Kids Arrives With Mounting Data: Kevin Kaiserman, MD

New data presented at the 86th Scientific Sessions of the American Diabetes Association (ADA) reinforce the safety and efficacy of inhaled insulin (Afrezza; MannKind Corporation) across multiple patient populations, building on its May 2026 FDA approval for pediatric use in children aged 6 and older. In youth with well-controlled diabetes (hemoglobin A_1C [HbA_1c] ≤ 9.5%), inhaled insulin achieved noninferior mean HbA_1c and comparable time-in-range vs rapid-acting analogs after 26 weeks, while pediatric patients achieving HbA_1c < 8% at 26 weeks reported statistically greater treatment satisfaction across both teens and parents.

According to Kevin Kaiserman, MD, senior vice president and therapeutic area head for diabetes at MannKind Corporation, low awareness among clinicians and patients remains a central challenge for inhaled insulin adoption. The ADA's updated 2026 Standards of Care may lend some support to that conversation: the guidance now calls for discussions about all insulin delivery methods—including inhaled insulin—at every patient visit, framing the choice as part of shared decision-making.

Data from the INHALE-1 (NCT04974528) pediatric trial reported improved treatment satisfaction among adolescents and parents of younger children compared with subcutaneous insulin. Kaiserman suggested the product's mealtime dosing flexibility—administered with the first bite of food—may be a contributing factor, particularly for pediatric patients with variable daily schedules.

On pulmonary safety, 2 real-world evidence studies published earlier this year in Diabetes Technology & Therapeutics found no statistically significant association between inhaled insulin use and long-term lung cancer risk when compared with subcutaneous insulin. A third retrospective analysis from ADA reports consistent findings in a separate dataset. Kaiserman noted that inhaled insulin has more than a decade of postmarketing history without new safety signals, though long-term independent surveillance data remain limited.

Whether the accumulating evidence translates into broader clinical adoption will likely depend on how effectively the findings reach prescribers.

Reference

Data at ADA 2026 highlights key findings from clinical and real‑world studies of MannKind’s Afrezza (inhaled insulin) across pediatric care, pregnancy, and use with automated insulin delivery (AID) systems. News release. MannKind. June 5, 2026. Accessed June 5, 2026.