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).
MannKind supported its latest label update with modeling data and in vivo results from its Dose Optimization study and INHALE-3 trial. Outcomes included postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose.
“We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind Corporation. “We believe this refinement to the label helps support appropriate initiation of therapy while reinforcing Afrezza’s established clinical profile.”
The tabel below outlines the updated dosing conversions:
| Current Subcutaneous Mealtime Insulin Dosage | Starting Dosage of AFREZZA |
| Up to 3 units | 4 units |
| 4 to 5 units | 8 units |
| 6 to 7 units | 12 units |
| 8 or more units | 16 units |
