The submission, if ultimately approved, would enable MannKind to bring Afrezza to children and adolescents (aged 4-17).
Afrezza is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion of the insulin cartridge, then the user closes it. The only other component is a mouthpiece for the sake of cleanliness. Then, the inhalation takes just two seconds. It requires no electronics or extra components.
MannKind Director of Medical and Scientific Engagement Joanne Rinker, MS, RDN, BC-ADM, CDCES, LDN, FADCES, told Drug Delivery Business News at ADA 2025 that a submission was on the way for children and adolescents aged 4-17 years old. Further data shared at ADA found Afrezza both safe and effective in that age range.
The company said in August that it submitted a supplemental Biologics License Application (sBLA) for Afrezza in the pediatric population.
MannKind said that, with the FDA’s acceptance of the sBLA, it was assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.
“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, SVP, 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.”
Afrezza first recieved FDA approval for adults (age 18 and up) in June 2014.
