AFREZZA® (Insulin Human) Inhalation Powder: Pediatric First Approval.

AFREZZA® (insulin human) inhalation powder is a drug-device combination product consisting of a dry powder formulation of rapid-acting recombinant human insulin adsorbed onto proprietary Technosphere® carrier particles, and a breath-powered oral inhaler. The powder is aerosolized and delivered to the lungs by the patient inhaling through the device. AFREZZA® (insulin human) inhalation powder has been developed by MannKind Corporation to improve glycemic control in patients with diabetes mellitus and received its first approval in the USA in 2014 for this indication in adult patients. More recently (29 May 2026), AFREZZA® (insulin human) inhalation powder received its first pediatric approval in the USA to improve glycemic control in pediatric patients 6 years of age and older with diabetes mellitus. This article summarizes the milestones in the development of AFREZZA® (insulin human) inhalation powder leading to this first pediatric approval for diabetes mellitus.