USFDAMay 28, 2026, 08:42 AM
MannKind Released from Afrezza Postmarketing Requirement; Pediatric PDUFA May 29
AI Summary
MannKind announced that the FDA has released the company from a significant five-year postmarketing requirement for Afrezza, which assessed the risk of pulmonary malignancy. This leaves only the pediatric efficacy and safety assessment as a remaining postmarketing requirement. Additionally, the FDA has set a PDUFA target action date of May 29, 2026, for the supplemental Biologics License Application for Afrezza in pediatric patients. The company also provided an update on its INHALE-1st clinical study, activating eight new sites to enroll participants.
Key Highlights
- FDA released MannKind from the five-year postmarketing requirement for Afrezza, assessing pulmonary malignancy risk.
- The only remaining postmarketing requirement for Afrezza is an assessment of its efficacy and safety in pediatric patients.
- A supplemental BLA for Afrezza in children and adolescents (4-17) has a PDUFA target action date of May 29, 2026.
- Eight additional sites have been activated for the INHALE-1st study, evaluating Afrezza in youth aged 10-17 with newly-diagnosed type 1 diabetes.
- The INHALE-1st study expects to enroll up to 100 participants across 10 clinical sites.
- Data from the INHALE-1st study is expected to be available in late 2027.
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