MannKind Seeks FDA Pediatric Afrezza Approval by May 29, Showcases New ADA Data
MNKD•New analyses from MannKind’s INHALE-1 trial will reveal 26-week A1c changes in children and adolescents with baseline HbA1c ≤9.5%, youth treatment satisfaction, automated insulin delivery compatibility and gestational diabetes outcomes at ADA 2026. A PDUFA target action date for pediatric Afrezza is set for May 29, 2026.
1. New Clinical and Real-World Insights
MannKind will present subgroup analyses from the INHALE-1 study detailing 26-week A1c changes in children and adolescents with baseline HbA1c ≤9.5%, post-hoc youth treatment satisfaction for those achieving HbA1c <8%, exploratory use of inhaled insulin with automated insulin delivery systems for prandial and correction dosing, and a randomized crossover assessment of inhaled insulin versus rapid-acting analogs in gestational diabetes.
2. Upcoming FDA Pediatric Approval Decision
The FDA has set a PDUFA target action date of May 29, 2026 for the supplemental Biologics License Application seeking approval of Afrezza for patients aged 4–17. Approval would mark the first needle-free insulin option for pediatric diabetes, potentially expanding MannKind’s market reach and encouraging earlier patient adoption.
3. Poster Presentations at ADA Sessions
Nine posters will be presented June 6–8 at the ADA Scientific Sessions in New Orleans, covering Technosphere insulin’s pharmacodynamic profile versus lispro, the impact of total daily dose algorithms in AID systems, real-world lung cancer risk assessments, a retrospective review of TRx distribution under the Inflation Reduction Act, and inhaled insulin comparisons in gestational diabetes.
4. Broader Pipeline Research
In addition to Afrezza data, MannKind will showcase analyses of FUROSCIX furosemide injection for fluid overload in patients with diabetes, highlighting the company’s efforts to address cardiometabolic co-morbidities through multiple therapeutic modalities.
