• Enables dosing at the start of a meal, offering flexibility for children and adolescents as they manage school, sports, meals, and snacks throughout the day
  • Approval advances pediatric diabetes care by introducing a new inhaled mealtime insulin option recognized in the American Diabetes Association (ADA) Standards of Care alongside multiple daily injections (MDI) and insulin pumps
  • Approval is supported by results from the Phase 3 INHALE-1 study in pediatric patients, along with clinical efficacy and safety evidence generated across thousands of patients over the past 20+ years of Technosphere® inhaled insulin development
  • Eligible patients can access Afrezza today for $35 or less per month, with dedicated support through MannKind Cares

     

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza® (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes.

In the United States, more than 350,000 children and adolescents are living with diabetes, the majority of whom have type 1 diabetes and require lifelong insulin therapy. Afrezza delivers insulin into the bloodstream through the lungs using MannKind's proprietary Technosphere® drug-delivery platform, enabling rapid absorption of insulin into systemic circulation. Afrezza is an ultra rapid-acting inhaled insulin taken when you eat that more closely mimics the body's natural insulin response at mealtime.