Key takeaways:
- The FDA has accepted MannKind Corporation’s sBLA to expand the indication of Afrezza (insulin human) Inhalation Powder to include children and adolescents with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026.
- Supported by data from the Phase 3 INHALE-1 trial, the submission includes 52 weeks of safety and efficacy results comparing Afrezza plus basal insulin with multiple daily injections, with full findings set to be presented at ISPAD in November.
- “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,” said Kevin Kaiserman, MD, senior vice president at MannKind.
The FDA has accepted for review MannKind Corporation’s supplemental biologics license application (sBLA) seeking to expand the indication of Afrezza (insulin human) Inhalation Powder to include children and adolescents with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.1
Expanding treatment options for pediatric patients
“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,” said Kevin Kaiserman, MD, senior vice president and therapeutic area head, Endocrine Diseases at MannKind Corporation. “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.”
If approved, Afrezza would become the first rapid-acting inhaled insulin available to pediatric patients, potentially addressing a long-standing need for alternatives to injectable therapies.
Clinical data supporting the application
The sBLA submission is supported by results from the Phase 3 INHALE-1 study, a 26-week open-label, randomized clinical trial that enrolled children and adolescents aged 4 to 17 years with either type 1 or type 2 diabetes. The study evaluated the efficacy and safety of Afrezza used in combination with basal insulin compared with multiple daily injections (MDI) plus basal insulin.
Topline data from the 6-month study were released in December 2024, and the submission also includes results from a 26-week extension phase, during which all remaining MDI participants transitioned to Afrezza. Full findings will be presented at the International Society for Pediatric and Adolescent Diabetes (ISPAD) meeting in early November.
Background on Afrezza
Afrezza, a rapid-acting inhaled human insulin, was first approved by the FDA in June 2014 for adults aged 18 years and older with diabetes mellitus. It is also approved for use in India and Brazil and is recognized within the American Diabetes Association’s Standards of Care as a treatment option for adults with diabetes.
Michael Haller, MD, discusses inhaled insulin and Afrezza data for type 1 diabetes
