FDA Approves MannKind's Inhaled Insulin for Children with Diabetes

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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