Shots:
- MannKind has enrolled the first patient in the P-II (INHALE-1st) trial assessing initiation of Afrezza(insulin human) Inhalation Powder in pediatric pts shortly after their type 1 diabetes diagnosis
- Trial will evaluate Afrezza over 13wks., followed by an optional extension phase for pts continuing to use Afrezza with basal insulin up to 26wks., assessing the proportion of CGM users achieving ≥70% time-in-range (70–180mg/dL) during the 14 days before wk. 13 (1EP)
- Additionally, in Oct 2025, the FDA accepted an sBLA for Afrezza Inhalation Powder in children & adolescent pts with type 1 or type 2 diabetes (PDUFA: May 29, 2026)
Ref: Globenewswire | Image: MannKind | Press Release
Related News: MannKind Reports the US FDA’s sBLA Acceptance of Afrezza (Inhaled Insulin) for Children and Adolescents with Diabetes
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