FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes

MannKind Corporation has announced the US Food and Drug Administration (FDA) acceptance of the supplemental biologics license application (sBLA) seeking approval for insulin human (Afrezza) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes.1

According to an October 13, 2025, release from the Company, the application is supported by results from the phase 3, 26-week, open-label INHALE-1 study and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.1

“Today’s milestone brings us one step closer to offering young children and teenagers living with diabetes a potential alternative therapy to multiple daily injections or an insulin pump system,” Kevin Kaiserman, MD, Senior Vice President, Therapeutic Area Head, Endocrine Diseases at MannKind Corporation, said in a statement.1 “Inhaled insulin has been available to adults for over a decade, and we are excited about the potential of adding this treatment choice for the pediatric population.”

Insulin human Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. Approved by the US Food and Drug Administration in 2014, the first New Drug Application for the agent was filed in 2009. Following a Complete Response Letter, a resubmission, and an advisory committee, the agent received approval for adults in June 2014.2

The sBLA for use in children and adolescents is based on results from the phase 3 INHALE-1 study in individuals 4-17 years of age living with either type 1 or type 2 diabetes. The 26-week open-label, randomized clinical trial evaluated Insulin human Inhalation Powder in combination with basal insulin versus multiple daily injections (MDI) with basal insulin.1,3

Six-month topline results from INHALE-1 were reported in December 2024. While an analysis of the full intent-to-treat population (ITT) found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), investigators noted this difference was driven by the variability of a single patient who did not adhere to the study protocol. Of note, a modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing noninferiority to MDI, which was the primary endpoint of the study.3

During 26 weeks of treatment, no difference in lung function parameters were observed between the treatment groups. Results showed Afrezza-treated patients had a mean FEV1 of 2.901 liters (99.6% of predicted) at baseline and 2.934 liters (96.6% of predicted) at 26 weeks. MDI-treated patients had corresponding mean FEV1 values of 2.948 liters (102.3% of predicted) and 2.957 liters (98% of predicted), respectively. Additional safety findings, including for hypoglycemia, did not show any significant concerns or differences between the treatment groups.3

As described in the press release from MannKind, the submission also included safety data from the study’s 26-week extension phase in which all remaining MDI patients switched to Insulin human Inhalation Powder. Full results will be shared at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November.1

References

1. MannKind. MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes. October 13, 2025. Accessed October 13, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental

2. Campbell P. Inhaled Insulin Could Improve Glycemic Control, HbA1c Compared to Usual Care in Type 1 Diabetes. HCPLive. June 22, 2024. Accessed October 13, 2025. https://www.hcplive.com/view/inhaled-insulin-could-improve-glycemic-control-hba1c-compared-to-usual-care-in-type-1-diabetes

3. MannKind. MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza®). December 16, 2024. Accessed October 13, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-six-month-results-phase-3-inhale-1-pediatric