MannKind Corporation (MNKD) has announced favorable outcomes from its six-month Phase 3 INHALE-1 clinical trial. This study assessed the effectiveness of Afrezza Inhalation Powder, a fast-acting inhaled insulin, in participants aged 4 to 17 years.
During the INHALE-1 trial, participants were randomly assigned to receive either Afrezza or multiple daily injections (MDI) of rapid-acting insulin. After a 26-week treatment period, there were no notable differences in lung function parameters between the two groups. This finding confirms that Afrezza is non-inferior to MDI, satisfying the primary objective of the study.
MannKind intends to consult with the FDA in the first half of 2025 to discuss the potential submission of a supplemental new drug application (sNDA).
