Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion of the insulin cartridge, then the user closes it. The only other component is a mouthpiece for the sake of cleanliness. Then, the inhalation takes just two seconds. It requires no electronics or extra components.

The approved update now revises recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. It marks the latest regulatory step for Afrezza, following the FDA’s acceptance of a supplemental biologics license last fall. That update would allow MannKind to bring Afrezza to children and adolescents (aged 4-17).