FDA Expands Afrezza to Pediatric Diabetes - Takeaways - MDSpire

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.

  • By

  • Kathryn Wighton

  • May 29, 2026

  • 3 min

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  • 1

    The FDA has approved Afrezza for children aged 6 and older with type 1 or type 2 diabetes.

  • 2

    Afrezza is an inhaled mealtime insulin that is administered using a portable inhaler.

  • 3

    The approval was supported by data from the INHALE-1 trial and over 20 years of inhaled insulin studies.

  • 4

    Afrezza offers a needle-free option for mealtime insulin, addressing challenges faced by pediatric patients.

  • 5

    Afrezza is not suitable for patients with chronic lung diseases and requires lung function assessments.

Original Source(s)

FDA Expands Afrezza to Pediatric Diabetes

  • by Kathryn Wighton

  • May 29, 2026

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