INHALE-1ST evaluates the initiation of Afrezza inhalation powder therapy shortly after type 1 diabetes diagnosis in pediatric patients.
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 FDA last month approved an update that 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) with type 1 and type 2 diabetes. It remains in progress with a PDUFA target action date of May 29, 2026.
If approved, Afrezza would become the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy, MannKind says.
Ahead of this potential approval, INHALE-1ST assesses the safety and effectiveness of Afrezza in combination with subcutaneously injected basal insulin once daily in children aged 10-18 newly diagnosed with type 1 diabetes. The study examines clinical outcomes and participant and caregiver satisfaction.
The first enrollment took place at the Barbara Davis Center for Diabetes in Aurora, Colorado. MannKind expects around 10 clinical sites participating in the study of approximately 100 patients across the U.S. It follows participants for 13 weeks during the main phase followed by an optional extension phase for up to 26 weeks.
“Many of the innovations that transformed diabetes care—such as continuous glucose monitors (CGMs) and insulin pumps—proved their full value and impact once they became available to pediatric patients,” said Michael Castagna, CEO of MannKind Corporation. “With nearly a decade of safety and real-world adult experience behind Afrezza, INHALE-1ST gives us an important opportunity to assess use earlier in the treatment journey for youth at the time of diagnosis so patients can potentially improve management of their mealtime glucose.”
