MannKind Secures FDA Approval of $35 Pediatric Afrezza Inhaled Insulin for Ages 6+
MNKD•MannKind won FDA approval for Afrezza inhalation powder in children aged 6 and older with type 1 and type 2 diabetes, based on Phase 3 INHALE-1 trial results. Eligible pediatric patients can obtain ultra rapid-acting Technosphere® insulin for $35 or less per month, addressing over 350,000 young Americans with diabetes.
1. FDA Approval and Indication
MannKind announced FDA approval of Afrezza Inhalation Powder for children and adolescents aged 6 and older with type 1 and type 2 diabetes. This marks the first and only ultra rapid-acting inhaled mealtime insulin approved for pediatric use in the U.S.
2. Clinical Evidence Supporting Approval
The approval is supported by pivotal Phase 3 INHALE-1 trial results in pediatric patients, along with two decades of clinical efficacy and safety data from thousands of patients using the Technosphere® platform. Inhaled delivery enables rapid insulin absorption, closely mimicking natural mealtime responses.
3. Market Impact and Patient Access
Afrezza is now available to eligible pediatric patients for $35 or less per month through MannKind Cares support, targeting over 350,000 children and adolescents living with diabetes in the U.S. This expands the company’s market beyond adult patients and offers a needle-free alternative for mealtime dosing.
