MannKind (MNKD) said Monday the six-month results of its phase 3 INHALE-1 study showed inhaled insulin Afrezza in children and adolescents aged four to 17 established the non-inferiority of Afrezza to multiple daily injections, which was the primary endpoint of the study.
The study compared Afrezza with multiple daily injections of rapid-acting insulin analogs, alongside basal insulin, over 26 weeks. Results from the modified intent-to-treat analysis confirmed that Afrezza met the non-inferiority threshold in HbA1c change compared with multiple daily injections.
No significant differences in lung function or safety, including hypoglycemia, were observed between the groups over the 26-week-period.
MannKind said it plans to meet with the FDA to discuss filing a supplemental new drug application in H1 2025.
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