(RTTNews) - MannKind Corporation (MNKD) Monday reported positive six-month results from its Phase 3 INHALE-1 study of Afrezza Inhalation Powder, a rapid-acting inhaled human insulin, in individuals aged 4-17 years of age.
In the INHALE-1 study, participants were randomized to receive either Afrezza or multiple daily injections (MDI) of rapid acting insulin. Over 26 weeks of treatment, no difference in lung function parameters were seen between the treatment groups. This established the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study.
The company plans to meet with the FDA regarding a potential supplemental new drug application (sNDA) in the first half of 2025.
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