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AFREZZA® (Insulin Human) Inhalation Powder: Pediatric First Approval

Sheridan M Hoy1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.

Paediatric Drugs
|August 18, 2026
PubMed

Insights

AFREZZA (insulin human) inhalation powder, a rapid-acting insulin, has gained FDA approval for pediatric patients aged 6 and older with diabetes mellitus. This milestone expands treatment options for glycemic control in younger populations using the Technosphere drug-device combination.

Area of Science:

  • Pharmacology
  • Drug Delivery Systems
  • Pediatric Endocrinology

Background:

  • AFREZZA (insulin human) is a rapid-acting recombinant human insulin product delivered via an oral inhaler.
  • It utilizes Technosphere carrier particles for efficient aerosolization and lung delivery.
  • MannKind Corporation developed AFREZZA for improving glycemic control in diabetes mellitus.

Purpose of the Study:

  • To summarize the development milestones of AFREZZA (insulin human) inhalation powder.
  • To highlight the recent pediatric approval for diabetes mellitus management.
  • To provide context for the drug-device combination's journey to market.

Main Methods:

  • Review of development history and regulatory submissions.
  • Analysis of clinical data supporting efficacy and safety in pediatric populations.
  • Examination of the drug-device combination's technological advancements.

Main Results:

  • AFREZZA (insulin human) received initial US FDA approval in 2014 for adult patients.
  • The drug-device combination achieved its first pediatric approval in the USA on May 29, 2026.
  • This approval is for improving glycemic control in pediatric patients aged 6 years and older with diabetes mellitus.

Conclusions:

  • The development of AFREZZA (insulin human) represents a significant advancement in inhaled insulin therapy.
  • The recent pediatric approval broadens the therapeutic options for managing diabetes in younger individuals.
  • This milestone underscores the potential of drug-device combinations for improved patient outcomes.

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