MannKind to Present Inhaled Afrezza Pediatric Data, FDA PDUFA Set for May 29, 2026
MannKind will present new clinical and real-world data on inhaled insulin Afrezza at ATTD 2026, highlighting dosing and titration patterns in youth from the INHALE-1 study and post-prandial glucose control across adult and pediatric patients. The FDA PDUFA target action date for Afrezza’s pediatric sBLA is May 29, 2026, potentially enabling the first needle-free insulin option for children aged 4-17.
1. ATTD 2026 Presentations
MannKind will deliver two oral presentations and one poster session at the Advanced Technologies & Treatments for Diabetes Conference in Barcelona on March 11–14, 2026. Sessions include a March 12 oral talk on post-prandial glucose control in Hall 212 at 5:10pm CET and a March 14 INHALE-1 pediatric study presentation in Hall 114 at 10:30am CET, showcasing real-world dosing and titration insights.
2. INHALE-1 Pediatric Study Findings
The INHALE-1 study evaluated Afrezza initiation and adjustment in children and adolescents with type 1 or type 2 diabetes, using an approximately 2:1 conversion from rapid-acting insulin analogs. Data highlighted how inhaled insulin dosing evolves over time, informing practical titration strategies for pediatric clinicians.
3. FDA Pediatric Review and Market Potential
An FDA review of Afrezza’s supplemental Biologics License Application for patients aged 4–17 is underway, with a PDUFA target action date of May 29, 2026. Approval would introduce the first needle-free insulin therapy for pediatric patients in over a century, potentially expanding MannKind’s addressable market.