MannKind Wins FDA Approval for Afrezza Inhaled Insulin in Children Ages 6 and Older
MannKind Corporation announced FDA approval of Afrezza inhaled mealtime insulin for pediatric patients with diabetes ages 6 and older. The approval makes Afrezza the first needle-free mealtime insulin alternative for children in over 100 years. Eligible patients can access Afrezza for $35 or less per month.
The U.S. Food and Drug Administration has approved MannKind Corporation's Afrezza inhaled mealtime insulin for pediatric patients with diabetes ages 6 and older, expanding the product's label into children and adolescents. The decision represents the first alternative to mealtime injections in over 100 years of pediatric diabetes treatment, according to the company.
The approval covers approximately 95% of children diagnosed with type 1 diabetes and is supported by results from the Phase 3 INHALE-1 clinical trial and more than 20 years of data on the Technosphere inhaled insulin platform. In the United States, more than 350,000 children and adolescents are living with diabetes, with the majority having type 1 diabetes and requiring lifelong insulin therapy.
Afrezza delivers insulin into the bloodstream through the lungs using MannKind's proprietary Technosphere drug-delivery platform, enabling ultra rapid-acting, needle-free dosing at the start of meals. The product peaks at about 45 minutes and clears around two hours, more closely mimicking the body's natural insulin response at mealtime compared to injectable rapid-acting insulin.
The INHALE-1 trial was a phase 3, open-label, randomized controlled study in youth ages 4 to 17 with type 1 or type 2 diabetes across 38 U.S. sites. The trial randomized 230 subjects, with 117 assigned to Afrezza plus basal insulin and 113 to rapid-acting injectable insulin plus basal insulin. Both groups used Dexcom G6 continuous glucose monitoring.
The primary endpoint was nominally missed, driven by one subject with a very high A1C who was documented as non-adherent to therapy. After removing that subject, a sensitivity analysis met the non-inferiority margin. Afrezza showed no change in body mass index percentile over 26 weeks, while the rapid-acting insulin analog group had a 3.6% increase, a statistically significant difference. Teens and parents reported significantly improved treatment satisfaction with Afrezza compared with subcutaneous insulin.
On pulmonary safety, there was no difference in change in percent predicted FEV1 between the Afrezza and rapid-acting insulin analog groups over the full study period. After week 26, all subjects used inhaled insulin, and those who switched from subcutaneous insulin to Afrezza showed no change in percent predicted FEV1 over the following six months.
MannKind's initial launch focus will be pediatric type 1 diabetes, targeting approximately 360,000 children and young adults ages 6 to 22 living with type 1 diabetes. The company cited about 30,000 newly diagnosed patients each year. The company is targeting a concentrated pediatric endocrinology market of roughly 60 key institutions and about 1,000 prescribers that treat the majority of pediatric patients, with 38 of those top 60 centers having participated in the clinical trial.
The company plans to make Afrezza available for $35 or less per month for anyone under age 23, regardless of insurance coverage. Afrezza is recognized in the American Diabetes Association Standards of Care as a mealtime insulin option alongside multiple daily injections and insulin pumps.
Afrezza is now approved for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes in the United States.