MannKind Corporation announced that FDA has accepted for review its supplemental Biologics License Application (sBLA) seeking to expand the label of Afrezza (insulin human) inhalation powder for use in children and adolescents aged 4 to 17 years with diabetes. Afrezza is currently approved in the United States to improve glycemic control in adults with type 1 and type 2 diabetes.
According to the company, the submission is supported by results from the INHALE-1 study, a multicenter Phase 3 clinical trial evaluating the safety and efficacy of inhaled insulin in pediatric patients compared with standard insulin therapy. The trial assessed outcomes such as hemoglobin A1c reduction, postprandial glucose control, and incidence of hypoglycemia across age and diabetes-type subgroups.
If approved, Afrezza would become the first ultra-rapid acting, inhaled mealtime insulin available for pediatric use. The product delivers insulin via a small breath-powered inhaler designed to provide fast onset and shorter duration of action compared with subcutaneous rapid-acting analogs.
The FDA’s acceptance of the sBLA triggers a standard review process to determine whether Afrezza’s benefits and safety profile support its expanded indication in younger patients. MannKind did not disclose the Prescription Drug User Fee Act (PDUFA) target action date. Pediatric diabetes experts note that additional treatment options could help improve adherence and quality of life among children who require multiple daily insulin doses.
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