MannKind Corporation Secures FDA Approval for Afrezza Inhaled Insulin for Children with Diabetes
MannKind Corporation has announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza, an inhaled insulin, for use in children and adolescents aged 6 and older with type 1 and type 2 diabetes. This approval marks a significant advancement in pediatric diabetes care, offering a new mealtime insulin option that is needle-free. Afrezza is administered at the beginning of meals using a small, portable inhaler, allowing for rapid absorption through the lungs. This method closely mimics the body's natural insulin response to meals. The approval is supported by the results of the Phase 3 INHALE-1 study and additional clinical data collected over two decades. Afrezza is now available for eligible patients at a cost of $35 or less per month, with support provided through MannKind Cares.