The FDA approved expanded use of MannKind's Afrezza inhaled rapid-acting insulin for children aged six and above with Type 1 and Type 2 diabetes on May 29, 2026. The product, first approved for adults in June 2014, offers a needle-free treatment option with eligible patients accessing it for $35 or less monthly. Afrezza is inhaled through a small device at mealtimes with rapid onset and short duration mimicking natural insulin response.
FDA approval expansion
- ▪The U.S. Food and Drug Administration approved expanded use of MannKind's inhaled rapid-acting insulin in children with diabetes on May 29, 2026
- ▪MannKind shares were up 6% in afternoon trading on May 29, 2026
- ▪MannKind's Afrezza is approved for use in children aged six and above with Type 1 and Type 2 diabetes
- ▪MannKind's Afrezza was first approved by the FDA for adults in June 2014
Afrezza inhaled insulin
- ▪MannKind's Afrezza has a rapid onset and short duration of action, more closely mimicking the body's natural insulin response to meals
- ▪MannKind's Afrezza is inhaled through a small device to help control blood sugar levels at mealtimes
- ▪Eligible patients can access MannKind's Afrezza for $35 or less a month
Patient experience benefits
- ▪Taisie Segrist, a 15-year-old who was part of MannKind's research study, initially needed several injections a day which was traumatizing for a child her age
- ▪Switching to inhaled insulin had been life changing for Taisie Segrist, making her more independent in managing diabetes
Needle-free treatment option
- ▪MannKind's Afrezza could cause serious side effects such as sudden lung problems
- ▪MannKind's inhaled rapid-acting insulin offers patients under 18 years of age a needle-free treatment option for diabetes
- ▪Conventional insulin is injected subcutaneously and could affect adherence especially in children
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