FDA Expands Afrezza to Pediatric Diabetes
The decision was supported by the phase 3 INHALE-1 trial and additional long-term safety, efficacy, and exposure data.
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By
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Kathryn Wighton
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May 29, 2026
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The FDA has approved Afrezza for children aged 6 and older with type 1 or type 2 diabetes.
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Afrezza is an inhaled mealtime insulin that is administered using a portable inhaler.
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The approval was supported by data from the INHALE-1 trial and over 20 years of inhaled insulin studies.
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Afrezza offers a needle-free option for mealtime insulin, addressing challenges faced by pediatric patients.
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Afrezza is not suitable for patients with chronic lung diseases and requires lung function assessments.
