Afrezza: Rapid-Acting Inhaled Insulin Approved for Children ≥ 6 Years Old with Diabetes 

Prepared on behalf of PES Drugs and Therapeutics Committee by Pranav Gupta, MD and edited by Dania Al-Hamad, MD and Neha Patel, DO  

Afrezza® (insulin human) inhalation powder is a drug and device combination product consisting of a rapid-acting Technosphere® insulin (TI) and an oral inhaler device (the Gen2 inhaler) that was initially approved in the US to improve glycemic control in adults with diabetes in June 2014. It is currently the only inhaled insulin approved and marketed in the USA.1 

On May 29, 2026, the Food and Drug Administration (FDA) approved Afrezza® powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes.2 

Results from the phase 3 INHALE-1 trial, a multicenter, open-label, randomized study, supported this approval. The study enrolled 230 youth (ages 4–17 years) with predominantly type 1 diabetes (98%) on multiple daily injections, randomized 1:1 to Technosphere® insulin (TI) or rapid-acting analog (RAA) insulin, used with basal insulin and a continuous glucose monitor, over 26 weeks.3 

The primary endpoint—change in HbA1c at 26 weeks—did not meet noninferiority (adjusted difference 0.18; 95% CI −0.07 to 0.43; P=0.091). Time in range was similar between groups, and rates of severe hypoglycemia were low (2 events with TI vs 1 with RAA). Pulmonary function measured by forced expiratory volume at 1 second (FEV1) remained unchanged.3  

Afrezza® has an ultra-rapid onset (~12 minutes), faster than rapid-acting insulin analogs (15–20 minutes), and a shorter duration of action that more closely mimics physiologic postprandial insulin secretion, potentially reducing late postprandial hypoglycemia.4 

Afrezza is contraindicated in patients with chronic lung disease (e.g., asthma, COPD) due to the risk of acute bronchospasm. All patients should undergo a thorough clinical assessment, including medical history, physical examination, and baseline spirometry (FEV1), prior to initiation. Spirometry should be repeated at 6 months and annually thereafter. 

For detailed dosing and conversion from subcutaneous rapid-acting insulin, refer to the Afrezza® prescribing information. 

References 

  1. Kim ES, Plosker GL. AFREZZA®(insulinhuman) Inhalation Powder: A Review in Diabetes Mellitus. Drugs. Sep 2015;75(14):1679–86. doi:10.1007/s40265-015-0472-0 
  2. MannKind Announces FDA Approval ofAfrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes. Accessed 06/16/2026,https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-afrezzar-first-and-only-inhaled 
  3. Haller MJ,KanapkaL, Monzavi R, et al. INHALE-1: A Multicenter Randomized Trial of Inhaled Technosphere Insulin in Children With Type 1 Diabetes. Diabetes Care. Jan 1 2026;49(1):179–187. doi:10.2337/dc25-1994 
  4. What is AFREZZA?Mannkind. Accessed 06/16/2026,https://afrezzahcp.com/ 
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