MannKind Corporation announced that the US FDA has approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older with type 1 and type 2 diabetes mellitus — marking the first approval of an inhaled mealtime insulin in the pediatric setting. The label expansion extends an adult indication first granted in 2014 and positions Afrezza as the only non-injectable prandial insulin option now available across both adult and pediatric populations in the United States.
Afrezza is administered at the start of a meal via a small, portable inhaler and must be used alongside basal insulin in patients with type 1 diabetes. The drug carries a boxed warning and is contraindicated in patients with chronic lung conditions, including asthma and chronic obstructive pulmonary disease, as well as those who currently smoke or have stopped smoking within the past six months. Prescribers are required to assess lung function before initiating therapy, with follow-up pulmonary monitoring at six months and annually thereafter. The drug is not approved for the treatment of diabetic ketoacidosis, and its safety in children under 6 has not been established.
The approval was supported by the Phase III INHALE-1 trial, a pivotal study evaluating Afrezza in pediatric patients with diabetes. The trial used rapid-acting subcutaneous insulin analogs — including insulin aspart and insulin lispro — as active comparators. MannKind said the study demonstrated efficacy and safety consistent with the established adult dataset, which spans more than two decades of Technosphere inhaled insulin development. Specific glycemic endpoints and numerical results from INHALE-1 were not disclosed in the company’s announcement.
The Technosphere platform
Afrezza’s ultra-rapid absorption profile is enabled by MannKind’s proprietary Technosphere drug-delivery technology, in which insulin human is formulated onto carrier particles that dissolve rapidly upon inhalation, facilitating systemic absorption through the pulmonary epithelium. The platform’s short duration of action is intended to more closely mirror physiologic postprandial insulin secretion than conventional subcutaneous analogs, which carry a longer tail of activity.
Afrezza enters the pediatric mealtime insulin space against an entrenched field of subcutaneous rapid-acting analogs. Novo Nordisk’s NovoLog (insulin aspart) and Eli Lilly’s Humalog (insulin lispro) — both of which served as active comparators in INHALE-1 — represent the current standard of care for prandial insulin delivery in children and adolescents with diabetes. The American Diabetes Association’s Standards of Care now lists inhaled insulin alongside multiple daily injections and insulin pumps as a recognized mealtime option, a designation MannKind cited as clinically significant. Whether the needle-free delivery route translates into meaningful adherence advantages in practice will likely depend on real-world uptake data that do not yet exist for this age group.