No Needles, No Pre-Bolus: Afrezza Is Now Approved for Kids 6 And Older With Diabetes

Parents of children and teens living with type 1 and type 2 diabetes, your daily routine is about to get a lot easier. Afrezza, the first inhaled and only needle-free mealtime insulin, has been approved by the Food and Drug Administration (FDA) for use in children aged 6 and older living with type 1 and type 2 diabetes.

What does this FDA approval mean for families?

This is a remarkable change for people and children living with diabetes. Afrezza, the only inhalable insulin in the world, was first approved for use in the United States in 2014, but only for adults 18 years and older. 

With nearly 500,000 children living with type 1 diabetes in the United States, the option to use Afrezza for mealtime boluses adds flexibility and options for diabetes management like never before. 

Afrezza has been known to help with stubborn high blood sugar levels, and now offering this treatment for kids will be revolutionary in care.

How does Afrezza work?

Afrezza delivers insulin to the bloodstream through the lungs using technosphere powdered insulin. This ultra-rapid-acting insulin hits the bloodstream almost immediately. It works by lowering blood sugar in as little as 12 minutes, which more closely mimics the release of insulin from the pancreas to prevent high blood sugars at mealtimes. 

Why is Afrezza helpful for children and teens?

This can be especially helpful for kids and teens when dealing with stubborn hormonal-related high blood sugars, unreliable mealtimes and complex snacks on the go. Diabetes for kids and teens can sometimes feel challenging, and blood sugar management downright impossible. Adding Afrezza to bring down blood sugars more quickly can be a game-changer. 

“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels and daily settings like school and sports often vary,” said Desmond Schatz, professor of pediatrics, University of Florida College of Medicine. “With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option.” 

What research supported the FDA decision?

This FDA approval is supported by results from the pivotal INHALE-1 clinical trial. The approval is also supported with added safety, efficacy and long-term exposure data from studies evaluating inhaled insulin over the past 20 years from first development until now.

“For more than a century, insulin therapy for children living with diabetes has largely meant multiple daily injections,” said Michael Castagna, PharmD, chief executive officer of MannKind Corporation. “Children and their families deserve new treatment options that fit the realities of daily life. Afrezza allows dosing at the moment of eating, without the need for pre-meal planning, making it a practical option for unplanned meals and snacks on the go. Our founder, Al Mann, would be proud of the dedication and teamwork that made it possible to bring this novel innovation to children and families.” 

How can families access Afrezza?

Afrezza is now available for children as young as 6 years old. If you or your child is interested in trying this therapy, speak with your healthcare provider. 

Afrezza is also available for eligible patients for only $35 or less per month. If you need support in accessing insurance coverage information, call MannKind Cares at 844-323-7399. 

If you are struggling to afford your insulin, get the resources you need at GetInsulin.org.