MannKind announced on May 29, 2026 that Afrezza, an inhaled rapid-acting mealtime insulin, was FDA-approved for children and adolescents aged 6 and older living with type 1 or type 2 diabetes. Reuters reported the expanded pediatric approval the same day, and Afrezza.com now describes the medicine as for adults and children ages 6 and older with diabetes who use mealtime insulin.
Quick summary
This is a new mealtime insulin option for some children and teens, but it is not a replacement for all insulin needs. Families should review lung history, glucose monitoring, basal insulin needs, and safety warnings with the diabetes care team before considering it.
Key takeaways
- Afrezza is inhaled at mealtime. It is not a long-acting or basal insulin.
- Children and teens with type 1 diabetes still need basal insulin if Afrezza is used for meals. Afrezza should never be used as the only insulin in type 1 diabetes.
- The FDA prescribing information carries a boxed warning about acute bronchospasm in people with chronic lung disease such as asthma or COPD.
- A lung history, physical exam, and spirometry are part of the safety screening described in the prescribing information.
- Afrezza is not recommended for diabetic ketoacidosis and is not recommended for people who smoke or recently stopped smoking.
What changed
MannKind announced that the FDA approved Afrezza for use in children and adolescents aged 6 and older with type 1 or type 2 diabetes. Reuters also reported the expanded approval for children with diabetes.
For families, the practical importance is that inhaled mealtime insulin may now be another option to discuss with a pediatric diabetes team. It may be relevant for children who struggle with mealtime injections, but suitability depends on medical history and day-to-day diabetes needs.
What Afrezza is
Afrezza is insulin human inhalation powder used around meals to help improve glycemic control. It is delivered through the lungs with a small inhaler. It is designed for mealtime glucose coverage, not for overnight or background insulin needs.
That distinction matters most for type 1 diabetes. Afrezza does not remove the need for basal insulin in type 1 diabetes and should never be used as the only insulin. Families should not stop injected or pump-delivered basal insulin unless a clinician gives a specific plan.
Safety checks families should know
The FDA prescribing information includes a boxed warning about acute bronchospasm in patients with chronic lung disease. It says Afrezza is contraindicated in chronic lung disease such as asthma or COPD, and that clinicians should assess lung history and perform spirometry before starting treatment.
The prescribing information also says Afrezza is not recommended for treatment of diabetic ketoacidosis and is not recommended in people who smoke or who recently stopped smoking. Common adverse reactions listed include hypoglycemia, cough, and throat pain or irritation.
Current patient safety information from Afrezza.com says lung function should be checked before starting, 6 months after starting, and yearly after that. It also tells patients to discuss lung cancer history, kidney or liver problems, pregnancy, breastfeeding, inhaled medicines, smoking, and recent smoking with a healthcare provider. It states that it is not known if Afrezza is safe and effective in children under 6 years of age.
Questions to ask the diabetes care team
- Is my child a possible candidate based on age, diabetes type, glucose patterns, and lung history?
- Would spirometry or other lung assessment be needed before starting?
- How would mealtime dosing be taught, monitored, and adjusted?
- If my child has type 1 diabetes, what is the basal insulin plan?
- What symptoms should prompt stopping the medicine or seeking urgent care?
- How should school, sports, meals, snacks, sick days, and CGM readings be handled?
Why this matters
Children and teens often manage diabetes across school, sports, meals, snacks, sleepovers, and changing routines. A non-injected mealtime insulin option may reduce one barrier for some families, but it also adds a different set of safety checks.
The most useful conversation is not whether inhaled insulin is better for everyone. It is whether this specific child has the right medical profile, support, monitoring plan, and insulin regimen for it to be used safely.
Practical takeaway
Families should treat this as a new option to discuss, not a medicine to seek or switch to on their own. The decision should include the child or teen, caregivers, and the diabetes care team, with careful attention to lung history, hypoglycemia risk, basal insulin, and glucose monitoring.
Safety note
Do not start, stop, or change insulin without medical guidance. Seek urgent care for severe low blood sugar, trouble breathing, wheezing, persistent vomiting, ketones, symptoms of diabetic ketoacidosis, or any symptoms that feel unsafe.
Related Livingdiabetes guides
Sources
- MannKind Announces FDA Approval of Afrezza, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes, MannKind Corporation. May 29, 2026. Used for: approval announcement and study/supporting context. Source
- US FDA approves MannKind’s inhaled insulin for children, Reuters, republished by Investing.com. May 29, 2026. Used for: independent news confirmation. Source
- Afrezza Important Safety Information, Afrezza.com, MannKind Corporation. May 2026. Used for: current patient-facing indication and safety information. Source
- Afrezza Prescribing Information, U.S. Food and Drug Administration. Revised January 2026. Used for: boxed warning, limitations of use, contraindications, adverse reactions, and safety framing. Source
- Breakthrough T1D Celebrates FDA Approval of Afrezza for Use in Children and Adolescents With Type 1 Diabetes, Breakthrough T1D. May 29, 2026. Used for: patient advocacy context for type 1 diabetes. Source