Clinical Deep-Dive · Endocrinology

FDA Approves Afrezza Label Update: Mealtime Dosage and Pump Transition

August 24, 2026

Afrezza pediatric indication

6 years of age and older

Afrezza cartridge strengths

4 units, 8 units, 12 units

sBLA approval date

01/23/2026

Prescribing information revision

05/2026

Dexcom Stelo OTC clearance date

06/12/2026

Exubera pediatric trial N

121

Clinical Perspective

- Specific patient eligibility criteria for the Afrezza label include adults and pediatric patients 6 years of age and older with diabetes mellitus who do not have chronic lung disease such as asthma or COPD and who are not current smokers; clinicians should evaluate baseline pulmonary function prior to initiation and periodically thereafter and consider Afrezza as an inhaled mealtime insulin option for patients meeting labeled criteria while recognizing labeled pulmonary safety monitoring requirements ^[1].

Dr. Amit Desai, MBBS, MD (General Medicine), DM (Endocrinology) · Endocrinology

Afrezza (insulin human) inhalation powder received FDA approval for a supplemental biologics license application (sBLA) that revises the Recommended Starting Mealtime Dosage section and updates the Instructions for Use to reflect transition from insulin pumps to Afrezza in combination with basal insulin; the approval letter is dated 01/23/2026 (exact figure not confirmed in public source summary) and the prescribing information was revised in 05/2026 ^[2]^[1]. Afrezza is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older; dosing is delivered via single-use inhalation cartridges of 4 units, 8 units, or 12 units and specific conversion recommendations are provided for switching from injected mealtime insulin to Afrezza (consult current prescribing information for full dosing guidance) ^[1]. The FDA also cleared an over-the-counter continuous glucose monitor (Dexcom Stelo Glucose Biosensor System) for children aged 2 years and older who do not use insulin on June 12, 2026, creating a regulatory landscape in 2026 that includes an inhaled mealtime insulin option for children ≥6 years and an OTC pediatric CGM for some children ≥2 years ^[3]^[1].

Clinical Context

Afrezza is a rapid-acting inhaled human insulin product with labeled indications to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus ^[1]. The Afrezza prescribing information indicates the product is for oral inhalation use only and must be administered at the beginning of each meal using the AFREZZA Inhaler ^[1]. The label includes specific administration instructions, a recommended starting mealtime dosage conversion table when switching from other mealtime insulin regimens, and guidance to modify mealtime dosing based on metabolic needs, blood glucose monitoring results, and glycemic control goals ^[1].
The FDA sBLA approval letter dated 01/23/2026 (exact figure not confirmed in public source summary) confirms that the supplemental application provided revisions to section 2.3 Recommended Starting Mealtime Dosage of the Afrezza Prescribing Information and updates to the Instructions for Use to reflect transition from insulin pumps to Afrezza in combination with basal insulin; the letter directs submission of the updated structured product labeling and labeling materials within 14 days ^[2]. The sBLA was submitted under section 351(a) of the Public Health Service Act and was approved effective on the date of the letter ^[2].
For continuous glucose monitoring, the FDA cleared the Dexcom Stelo Glucose Biosensor System for over-the-counter marketing for children two years of age and older who do not use insulin; the device displays glucose measurements and trends every 15 minutes and each sensor lasts for up to 15 days (exact figure not confirmed in public source summary), with the FDA noting that sensor wear time may be shorter in pediatric users than in adults ^[3]. The Stelo clearance specifies the device is indicated for people two years of age and older who do not use insulin, including children with diabetes who receive oral medication, and that users and caregivers should consult a healthcare provider before making medication adjustments based on device output ^[3].
Information about automated closed-loop (hybrid or fully closed-loop) insulin delivery systems, commercial pediatric insulin pump options, and interoperability between Afrezza and automated pump algorithms is not reported in the provided source excerpts. Specific pediatric comparative effectiveness data linking inhaled insulin plus basal regimens to closed-loop systems in children is not reported in the provided source excerpts.

Key Findings

Regulatory action and labeling: The FDA approved the Afrezza sBLA effective 01/23/2026 (exact figure not confirmed in public source summary), approving revisions to the Recommended Starting Mealtime Dosage and updates to the Instructions for Use to reflect the transition from insulin pumps to Afrezza in combination with basal insulin; the approval letter and agreed-upon labeling were issued to MannKind Corporation and require submission of the SPL within 14 days ^[2]. The Afrezza Prescribing Information highlights the product’s indication to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus and lists recent major changes including Indications and Usage revised 5/2026 and Dosage and Administration changes 5/2026 and 1/2026 ^[1].
Afrezza dosing and administration specifics from the prescribing information: Afrezza is administered via oral inhalation using the AFREZZA Inhaler at the beginning of each meal with one inhalation per cartridge; cartridges deliver 4 units, 8 units, or 12 units of insulin human as inhalation powder and combinations of cartridges may be used to achieve required mealtime dosages ^[1]. The label provides a conversion table for switching from subcutaneous mealtime insulin to Afrezza: "Up to 3 units" injectable → "4 units" Afrezza; "4 to 5 units" → "8 units"; "6 to 7 units" → "12 units"; "8 or more units" → "16 units" (and notes that combinations of cartridges should be used for doses exceeding a single cartridge) ^[1]. The prescribing information directs that dosage should be modified based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal, and that if blood glucose control is not achieved with increased Afrezza dosages, consider discontinuing Afrezza ^[1]. Training requirements and self-administration: prior to initiation, train patients and/or caregivers on administration; after training, adult and pediatric patients aged 10 and older may self-administer Afrezza if the healthcare provider determines it appropriate ^[1]. The AFREZZA Inhaler may be used for up to 15 days from first use and must be discarded after 15 days ^[1].
Pulmonary function monitoring and pulmonary safety signals in the label: Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD because of the risk of acute bronchospasm, and the label requires pulmonary function assessment (spirometry, FEV1) at baseline, after 6 months of therapy, and annually thereafter even in the absence of pulmonary symptoms; consider discontinuing Afrezza for a decline of ≥ 20% in FEV1 from baseline ^[1]. The label specifically reports bronchoconstriction and wheezing following AFREZZA dosing in a study of patients with asthma: 29% (5/17) of patients with a diagnosis of asthma had bronchoconstriction and wheezing versus 0% (0/13) of patients without asthma (exact figure not confirmed in public source summary), and a mean decline in FEV1 of 400 mL (exact figure not confirmed in public source summary) was observed 15 minutes after a single AFREZZA dose in patients with asthma. In a subset of 8 patients with COPD, a mean decline in FEV1 of 200 mL (exact figure not confirmed in public source summary) was observed 18 minutes after a single AFREZZA dose ^[1].
Historical inhaled-insulin pediatric trial data in the sources: a randomized, parallel 12-week trial of Exubera (an inhaled human insulin formulation studied previously) in children ages 6 to 11 years (n=121) comparing Exubera to subcutaneous insulin plus intermediate/long-acting insulin reported that decreases from baseline HbA1c were comparable between treatment groups, with the difference between adjusted mean decrease from baseline (EXU - SC insulin) of -0.23 (95% CI, -0.49, 0.03) (exact figure not confirmed in public source summary) ^[4]. In that study, mild to moderate cough occurred in 24.6% of EXU patients versus 6.8% of SC insulin patients; the risk for hypoglycemia was comparable (relative risk 0.88; 95% CI 0.71-1.11) ^[4]. These historic Exubera data provide pediatric inhaled-insulin efficacy and safety context but are separate from the Afrezza label and the Afrezza sBLA described in the approval letter ^[4]^[2]^[1].
OTC pediatric CGM clearance details: the FDA cleared the Stelo Glucose Biosensor System OTC for children two years of age and older who do not use insulin; the system displays glucose measurements and trends every 15 minutes, each sensor lasts up to 15 days (exact figure not confirmed in public source summary), and the FDA noted prior study participants reported mild adverse events including local infection, skin irritation, and pain or discomfort ^[3]. The FDA stated the clearance was supported by clinical study data from pediatrics and adults plus real-world evidence ^[3].

Safety & Tolerability

Afrezza-labeled adverse reactions and safety findings include hypoglycemia; cough; throat pain or irritation (adverse reactions ≥2% incidence); acute bronchospasm and wheezing in patients with asthma or COPD leading to contraindication in chronic lung disease; declines in pulmonary function with a recommendation to assess spirometry (FEV1) at baseline, after 6 months, and annually and to consider discontinuing Afrezza for a decline of ≥ 20% in FEV1 from baseline; reported bronchoconstriction/wheezing in a study of patients with asthma (29% [5/17] vs 0% [0/13]) and mean declines in FEV1 of 400 mL and 200 mL after a single dose in asthma and COPD subsets respectively (exact figures not confirmed in public source summary); the label also notes a potential lung cancer concern in patients with active or prior lung cancer, hypersensitivity reactions including anaphylaxis, hypokalemia, fluid retention and heart failure with concomitant use of PPAR-gamma agonists, and that Afrezza is not recommended for treatment of diabetic ketoacidosis (DKA) ^[1].

Study Design

The approval letter and prescribing information references supporting clinical data and label changes but detailed trial design elements linking Afrezza transition from insulin pumps to Afrezza in combination with basal insulin are not provided in the cited source excerpts ^[2]^[1]. Historical pediatric inhaled-insulin study cited (Exubera) was a 12-week randomized, parallel trial in children ages 6 to 11 years comparing inhaled Exubera to subcutaneous insulin plus intermediate/long-acting insulin (n=121) with change in HbA1c as the primary efficacy endpoint ^[4].

FDA Approves Afrezza Label Update: Mealtime Dosage and Pump Transition

Direct Clinical Takeaway & Evidence Summary

FDA Approves Afrezza Label Update: Mealtime Dosage and Pump Transition

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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