INHALE-1 looked at Afrezza in children and adolescents between 4-17 years of age. The company expects the data to support an upcoming request for a supplemental new drug application (sNDA) meeting with the FDA. It aims to set that up for the first half of 2025 with the hopes of discussing the data and filing timeline.

The 26-week, open-label clinical trial randomized 230 subjects to either Afrezza or multiple daily injections (MDI). The MDI group received rapid-acting insulin analog (RAA) in combination with basal insulin. INHALE-1 had a primary endpoint of non-inferior change in HbA1c levels after 26 weeks. The company also has an ongoing 26-week extension phase in which all remaining MDI patients switched to Afrezza.