FDA Accepts MannKind’s Application to Expand Afrezza Inhaled Insulin Use to Children and Teens
If approved, Afrezza would become the first inhaled insulin option for patients as young as four years old.
MannKind Corporation (NASDAQ: MNKD) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for the company’s inhaled insulin therapy Afrezza, seeking approval for use in children and adolescents aged 4 to 17 living with diabetes.
The FDA’s acceptance of the filing establishes a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026, marking a key regulatory milestone as MannKind works to expand access to its innovative, needle-free insulin delivery system.
Afrezza is a rapid-acting inhaled insulin powder designed to be administered through a small, mechanical inhaler that requires no electronics or complex components. Users simply insert an insulin cartridge, close the compartment, and inhale for approximately two seconds. The device delivers insulin directly to the lungs, allowing for faster absorption than traditional subcutaneous injections.
“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 Dr. Kevin Kaiserman, Senior Vice President and Therapeutic Area Head, Endocrine Diseases at MannKind. “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.”
The submission follows positive data presented at the American Diabetes Association (ADA) 2025 conference, where Afrezza demonstrated both safety and efficacy in children and adolescents with diabetes. According to Joanne Rinker, MS, RDN, BC-ADM, CDCES, LDN, FADCES, MannKind’s Director of Medical and Scientific Engagement, the pediatric submission had been anticipated following these findings.
MannKind first announced its intent to file the sBLA in August 2025, after completing clinical studies evaluating Afrezza’s use in younger patients.
A New Option for Pediatric Diabetes Care
If approved, the expanded indication would mark a significant step in the evolution of diabetes treatment for children — a population that currently relies on multiple daily injections or insulin pump systems. Afrezza’s inhaled format offers a non-invasive alternative designed to improve treatment adherence and quality of life.
Afrezza was initially approved by the FDA in June 2014 for use in adults aged 18 and older. MannKind has since continued to refine the delivery platform and expand its clinical program to new patient populations.
