FDA approval expands Afrezza as an inhaled mealtime insulin option for pediatric patients with diabetes aged 6 years and older.
The US Food and Drug Administration has approved
Afrezza is administered at the beginning of meals using a portable inhaler and delivers insulin through the lungs via MannKind’s Technosphere drug-delivery platform. The agent was first approved by the FDA in June 2014 to improve glycemic control in adults with
The pediatric approval was supported by findings from the phase 3 INHALE-1 (NCT04974528) clinical trial in pediatric patients, along with additional safety, efficacy, and long-term exposure data from studies of inhaled insulin conducted over more than 2 decades, according to the company announcement.1
Key Facts
The decision adds a needle-free mealtime insulin option for children and adolescents who require prandial insulin, although Afrezza remains subject to pulmonary safety restrictions and monitoring requirements. The product is not indicated for diabetic ketoacidosis and must be used with basal insulin in patients with type 1 diabetes.1
According to the Centers for Disease Control and Prevention’s National Diabetes Statistics Report, 352 000 children and adolescents younger than 20 years in the United States have diagnosed diabetes, including 304 000 with type 1 diabetes.3 For children and families, mealtime insulin can be difficult to align with variable eating patterns, school schedules, physical activity, and snacks.
“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary,” Desmond Schatz, MD, professor of pediatrics at the University of Florida College of Medicine, said in the announcement. “With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option.”1
Current pediatric diabetes management typically centers on individualized intensive insulin therapy using multiple daily injections, insulin pumps, or automated insulin delivery systems, along with glucose monitoring and education for children, families, and school personnel.4 For many children with type 1 diabetes, prandial insulin timing, variable appetite, physical activity, and unplanned snacks complicate day-to-day glycemic management. An inhaled mealtime option may be clinically relevant for selected patients who have difficulty with injections or premeal dosing, but it does not remove the need for basal insulin in type 1 diabetes or comprehensive diabetes self-management support.
The prescribing information includes a boxed warning for acute bronchospasm in patients with chronic lung disease.
The most common adverse effects include hypoglycemia, cough, and throat pain.
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