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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07679893 |
Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis |
RECRUITING | PHASE2 |
| NCT07344558 |
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis |
COMPLETED | PHASE1 |
| NCT07224321 |
INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes |
RECRUITING | PHASE2 |
| NCT06880835 |
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RECRUITING | NA |
