USFDAMay 29, 2026, 12:31 PM
MannKind Afrezza FDA Approved for Pediatric Type 1 & 2 Diabetes
AI Summary
MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. This approval expands Afrezza's availability beyond adults, offering a new needle-free mealtime insulin option that allows dosing at the start of a meal. The decision is supported by the Phase 3 INHALE-1 study and extensive clinical data, aiming to provide flexibility for pediatric patients managing their condition.
Key Highlights
- FDA approved Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 and older with type 1 and type 2 diabetes.
- Afrezza is an ultra rapid-acting inhaled insulin delivered via MannKind's Technosphere® platform.
- The approval is supported by results from the Phase 3 INHALE-1 study in pediatric patients.
- More than 350,000 children and adolescents in the U.S. live with diabetes.
- Eligible patients can access Afrezza for $35 or less per month through MannKind Cares.
Price Impact
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