DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2026
MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza® (insulin human) Inhalation Powder for children and adolescents aged 6 years and older with Type 1 or Type 2 diabetes. The approval makes Afrezza the first and only inhaled mealtime insulin available for pediatric patients, expanding treatment options beyond traditional insulin injections and pumps. The decision was supported by data from the Phase 3 INHALE-1 clinical trial and long-term safety and efficacy evidence generated during more than two decades of Technosphere® inhaled insulin development.
FDA Approval Brings First Inhaled Mealtime Insulin to Children
The FDA approval marks a significant advancement in pediatric diabetes management, providing young patients with a needle-free mealtime insulin alternative. Afrezza utilizes MannKind’s proprietary Technosphere® technology, delivering insulin through the lungs for ultra-rapid absorption into the bloodstream. The therapy is administered at the beginning of a meal and is designed to more closely mimic the body’s natural insulin response compared with conventional injected insulin. More than 350,000 children and adolescents in the United States live with diabetes, many of whom require lifelong insulin therapy, creating a substantial need for more flexible treatment options.
Phase 3 INHALE-1 Study Supports Pediatric Expansion
The approval was supported by results from the pivotal Phase 3 INHALE-1 trial, which evaluated Afrezza in pediatric patients with diabetes. Clinical findings demonstrated that the inhaled insulin provided effective glycemic control while maintaining a safety profile consistent with previous studies. Additional evidence from thousands of patients treated across more than 20 years of inhaled insulin research further strengthened the regulatory submission. According to the company, Afrezza’s rapid onset and short duration of action allow dosing at the start of meals without requiring extensive pre-meal planning, helping address the challenges of varying eating habits, school schedules, sports activities, and unplanned snacks common among children and adolescents.
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Expanded Access and Future Impact on Diabetes Care
MannKind stated that eligible patients can access Afrezza for $35 or less per month through its patient support initiative, MannKind Cares, which assists families and healthcare providers with reimbursement and access resources. Company executives and diabetes advocacy leaders noted that the approval introduces a meaningful new treatment option for pediatric patients and their caregivers. With inclusion in the American Diabetes Association (ADA) Standards of Care alongside multiple daily injections and insulin pump therapy, Afrezza is expected to broaden individualized treatment strategies and improve flexibility for children managing diabetes in everyday life. The approval also reinforces MannKind’s commitment to advancing innovative therapies for chronic diseases through patient-centric drug delivery technologies.
Source: MannKind press release
