USFDAMay 27, 2026, 09:06 AM
MannKind to present new Afrezza data at ADA; PDUFA date May 29
AI Summary
MannKind Corporation announced that new clinical and real-world data for Afrezza and FUROSCIX will be presented at the American Diabetes Association's 2026 Scientific Sessions. This comes as the company approaches the PDUFA target action date of May 29, 2026, for Afrezza's approval in pediatric patients. The presentations will cover various aspects including pediatric efficacy, patient satisfaction, use with AID algorithms, and gestational diabetes, further strengthening the understanding of inhaled insulin across diverse patient populations.
Key Highlights
- PDUFA target action date for Afrezza in children and adolescents is May 29, 2026.
- New clinical and real-world data for Afrezza and FUROSCIX to be presented at ADA 2026 Scientific Sessions (June 5-8).
- Data includes subgroup analysis on pediatric efficacy & A1c from INHALE-1 study.
- Post hoc analysis from INHALE-1 evaluates youth treatment satisfaction with inhaled insulin.
- Exploratory analysis examines inhaled insulin use with automated insulin delivery (AID) systems.
- Randomized crossover study evaluates inhaled insulin in gestational diabetes.
- Nine posters will showcase new clinical and real-world insights at ADA 2026.
- If approved, Afrezza would be the first needle-free insulin option for pediatric patients in over 100 years.
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