MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient centric solutions for cardiometabolic and orphan lung diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes.

In the United States, more than 350,000 children and adolescents are living with diabetes, the majority of whom have type 1 diabetes and require lifelong insulin therapy. Afrezza delivers insulin into the bloodstream through the lungs using MannKind’s proprietary Technosphere^® drug-delivery platform, enabling rapid absorption of insulin into systemic circulation. Afrezza is an ultra rapid-acting inhaled insulin taken when you eat that more closely mimics the body’s natural insulin response at mealtime.

“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.”

This approval expands Afrezza’s availability beyond adults, introducing a new mealtime insulin option for pediatric patients and caregivers. The FDA approval is supported by results from the pivotal INHALE‑1 clinical trial, along with additional safety, efficacy, and long‑term exposure data from studies evaluating inhaled insulin over the past two decades of development.

“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.”

“For families raising children with diabetes, every day is shaped by treatment decisions – and those decisions are deeply personal,” said Jeff Hitchcock, Founder, President and CEO of Children With Diabetes. “Having navigated those choices firsthand for my own child, I understand that what works for one child may not work for another, and parents know this better than anyone. The approval of Afrezza for pediatric use represents a meaningful step forward for children and adolescents living with diabetes, and for the families who support, advocate, and care for them every single day. It adds an important new option to the diabetes toolkit and signals continued progress toward more individualized care for kids and teens.”

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).