FDA Expands Approval of Afrezza Inhaled Insulin for Children Aged 6 and Up — First Needle-Free Pediatric Option

Taisie Seigrist, a 15-year-old track and cross-country athlete from Oklahoma, was diagnosed with Type 1 diabetes five years ago. "It was a big life shift," her mother, Jennifer Seigrist, recalled of the week Taisie spent in the hospital learning to get her blood sugar under control and to manage diabetes at home. Learning to dose and inject insulin was necessary but painful: "I kept getting bruises, and so it really hurt," Taisie said.

What Changed: FDA Expands Afrezza Approval

On Friday, the U.S. Food and Drug Administration expanded its approved use of Afrezza, an inhaled rapid-acting insulin manufactured by MannKind Corporation, to include children aged 6 years and older with Type 1 diabetes and patients who require insulin for Type 2 diabetes. This makes Afrezza the first needle-free insulin option approved for pediatric patients.

Clinical Trial Findings

Dr. Jamie Wood, an endocrinologist and medical director of pediatric diabetes at Rainbow Babies and Children's Hospital in Cleveland, Ohio, served as a lead investigator in the pediatric trial. The randomized study compared inhaled Afrezza with injected rapid-acting insulin and focused on both blood-glucose control and lung safety. Pulmonary function tests were followed through 52 weeks.

Jennifer Seigrist - PHOTO: Taise Seigrist, now 15, was diagnosed with type 1 diabetes at age 10.

"We demonstrated in the trial that when you compare [inhaled insulin] to injected insulin, the results are about the same," Wood said. "Pulmonary function was stable through the 52-week timepoint and we found no safety signals related to lung function."

Safety, Side Effects, and Contraindications

The most commonly reported side effects were hypoglycemia (low blood sugar), which is a risk with any insulin, and a temporary cough. Afrezza should not be used by people with asthma or other chronic lung diseases and is contraindicated for current smokers (including tobacco, marijuana, and e-cigarette/vaping products). It is also not intended to treat diabetic ketoacidosis.

How It’s Used

Afrezza is a short-acting inhaled insulin delivered via a small, discreet inhaler. Cartridges are color-coded for three dosing strengths. For people with Type 1 diabetes, inhaled Afrezza is used at mealtimes to cover carbohydrates or correct high blood glucose, while a long-acting basal insulin (an injection) is still required for background insulin needs.

Patient Experience and Accessibility

Taisie and her mother were satisfied with Afrezza’s effect on mealtime blood sugars during the trial and continued using it afterward, paying out of pocket until insurance coverage was arranged. Jennifer Seigrist said the treatment improved Taisie’s independence and mental well-being: "She's a lot more free — she feels like she can participate more with what everybody else is doing."

MannKind Corporation - PHOTO: Afrezza, an ultra rapid-acting inhaled insulin, is pictured here.

List prices can be high: GoodRx has shown monthly costs above $2,000 in some instances. MannKind says most patients pay $35 or less through Medicare caps or manufacturer programs that reduce commercial insurance out-of-pocket costs; the company has also offered a cash price around $99 per month for some patients, according to a MannKind spokesperson.

What Families Should Do Next

Families and patients interested in inhaled insulin should discuss the option with their child’s endocrinologist to review benefits, risks, dosing, pulmonary screening, and insurance coverage. Regular lung function monitoring and avoiding smoking are important parts of safe use.

Reporting and Authorship: Jade A. Cobern, MD, MPH, a practicing physician board-certified in pediatrics and general preventive medicine and a fellow of the ABC News Medical Unit, contributed medical context to the reporting.