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The U.S. Food and Drug Administration on May 29, 2026 approved an expanded label for MannKind Corporationâs rapidâacting inhaled insulin Afrezza for pediatric patients aged six and older with type 1 or type 2 diabetes.
The decision, based on the phase 3 INHALEâ1 trial (230 children, randomized, 26 weeks plus extension), relied on a prespecified sensitivity analysis showing noninferiority in HbA1c among children who completed and used inhaled insulin as directed.
Afrezza uses MannKindâs Technosphere platform â ultraâsmall FDKP particles that deliver insulin to the lungs in a twoâsecond breath, with systemic uptake within about one minute, peak action at 35â45 minutes and duration of roughly 1.5â3 hours.
The product was already approved for adults in 2014.
Company shares rose about 6% after the news and MannKind said eligible patients can access Afrezza for about $35 or less per month.
Regulators and investigators note safety caveats: potential for sudden lung problems, contraindications for smokers and not for treating diabetic ketoacidosis; Type 1 patients still require basal insulin.
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The American Journal of Managed CareFDA Approves Inhaled Insulin for Children, Adolescents With Diabetes







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