Key Takeaways:
The FDA approved MannKind's Afrezza inhaled insulin for children aged 6 and older, the first needle-free mealtime insulin option for pediatric patients in more than a century.
"Children and their families deserve new treatment options that fit the realities of daily life," Michael Castagna, chief executive officer of MannKind, said.
The approval covers both type 1 and type 2 diabetes in patients aged 6 to 17, expanding Afrezza's label beyond adults. The decision was supported by the Phase 3 INHALE-1 trial, a 26-week open-label study comparing Afrezza with multiple daily injections in patients aged 4 to 17, plus safety data from a 26-week extension phase. More than 350,000 children and adolescents in the US live with diabetes, the majority requiring lifelong insulin therapy.
Afrezza delivers insulin through the lungs using MannKind's Technosphere platform, enabling rapid absorption at the start of a meal without the need for injections. Eligible patients can access the drug for $35 or less per month through MannKind's patient support program.
"Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary," Desmond Schatz, professor of pediatrics at the University of Florida College of Medicine, said. "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."
"For families raising children with diabetes, every day is shaped by treatment decisions — and those decisions are deeply personal," Jeff Hitchcock, founder and chief executive officer of Children With Diabetes, said. "The approval of Afrezza for pediatric use represents a meaningful step forward."
MannKind will present nine posters at the American Diabetes Association's 2026 Scientific Sessions in New Orleans next week, including pediatric treatment satisfaction data and analyses of Afrezza's use with automated insulin delivery systems. The company also plans to showcase a virtual reality experience at its booth demonstrating how inhaled insulin works in the lungs.
Afrezza was first approved by the FDA for adults in June 2014 and is also approved in India and Brazil. The American Diabetes Association recognizes it in its Standards of Care as a mealtime insulin option alongside multiple daily injections and insulin pumps.
The pediatric approval opens a new market of more than 350,000 potential patients and positions MannKind as the only company offering a needle-free mealtime insulin for children. Investors will watch initial prescription data and the company's ability to secure insurance coverage for the expanded label.
This article is for informational purposes only and does not constitute investment advice.
