FDA Accepts MannKind sBLA for Inhaled Insulin for Children and Adolescents with Diabetes

The FDA today accepted MannKind Corporation's supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents aged 4–17 years with type 1 or type 2 diabetes. The FDA assigned a Prescription Drug User Fee Act target action date of May 29, 2026.¹

The application is based on results from the company's phase 3 INHALE-1 study, a 26-week open-label, randomized clinical trial that compared the inhaled insulin in combination with basal insulin to multiple daily injections (MDI) with basal insulin. MannKind reported topline results from the study in December 2024² and said that full results will be announced at the International Society for Pediatric and Adolescent Diabetes in early November.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, MannKind senior vice president and therapeutic are head of endocrine diseases, said in a statement. "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."¹

INHALE-1 Study Details

The INHALE-1 study met its primary endpoint of noninferiority to MDI. While an initial analysis of the full intent-to-treat (ITT) population found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified noninferiority margin of 0.4% (0.435%), investigators attributed this difference to the variability of a single participant who did not adhere to the study protocol. A modified ITT analysis excluding this subject did not exceed the threshold of 0.4% (0.370%), and so established the inhaled powder's noninferiority to MDI, the study's primary endpoint.²

Investigators observed no differences in lung function parameters between treatment groups, according to the company. Afrezza-treated participants 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, compared to corresponding FEV₁ values of 2.948 liters (102.3% of predicted) and 2.957 liters (98% of predicted) in MDI-treated patients.²

Review of additional safety findings, including hypoglycemia rates, showed no significant differences between the treatment groups and raised no other concerns.² The submission includes safety data from a 26-week extension phase of INHALE-1 in which all remaining MDI patients switched to Afrezza.

The FDA first approved Afrezza for adults aged 18 and older in June 2014 and the drug is also approved in India and Brazil. It is recognized as part of the American Diabetes Association's Standards of Care.

Afrezza At-A-Glance

References

1. 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. News release. MannKind. 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. MannKind announces six-month results from phase 3 INHALE-1 pediatric diabetes trial utilizing inhaled insulin (Afrezza). News release. MannKind. 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