MannKind Corporation announced FDA approval of Afrezza inhaled mealtime insulin for pediatric patients with diabetes ages 6 and older. The approval makes Afrezza the first needle-free mealtime insulin alternative for children in over 100 years. Eligible patients can access Afrezza for $35 or less per month.
FDA approves MannKind's Afrezza inhaled insulin for children aged 6+ with type 1 and type 2 diabetes. Separately, an updated label provides new starting dose guidance for adults switching from injections or insulin pumps.
MannKind Corporation has enrolled the first pediatric patient in its INHALE-1ST trial evaluating Afrezza inhaled insulin in children with type 1 diabetes. The FDA is reviewing a supplemental Biologics License Application with a decision expected by May 29, 2026.
