FDA accepts Afrezza sBLA for pediatric diabetes

FDA accepts Afrezza sBLA for pediatric diabetes | Image credit: Contemporary Pediatrics

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.

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.

Reference

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. Global Newswire. October 13, 2025. Accessed October 13, 2025. https://www.globenewswire.com/news-release/2025/10/13/3165519/29517/en/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-wit.html