Shots:
- The US FDA has accepted sBLA of Afrezza (insulin human) Inhalation Powder for the treatment of children & adolescents with type 1 or type 2 diabetes (PDUFA: May 29, 2026)
- sBLA was supported by P-III (INHALE-1), assessing Afrezza vs multiple daily injections (MDI), both in addition to basal insulin among type1/2 diabetic pts (4-17yrs.) for 26wks., with topline data reported in Dec 2024
- Submission also incl. 26wk. extension phase data where all remaining MDI pts switched to Afrezza; full results to be presented at the ISPAD’25
Ref: MannKind | Image: MannKind | Press Release
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