{"title":"AFREZZA<sup>®</sup> (Insulin Human) Inhalation Powder: Pediatric First Approval.","authors":"Sheridan M Hoy","doi":"10.1007/s40272-026-00768-z","DOIUrl":null,"url":null,"abstract":"<p><p>AFREZZA<sup>®</sup> (insulin human) inhalation powder is a drug-device combination product consisting of a dry powder formulation of rapid-acting recombinant human insulin adsorbed onto proprietary Technosphere<sup>®</sup> carrier particles, and a breath-powered oral inhaler. The powder is aerosolized and delivered to the lungs by the patient inhaling through the device. AFREZZA<sup>®</sup> (insulin human) inhalation powder has been developed by MannKind Corporation to improve glycemic control in patients with diabetes mellitus and received its first approval in the USA in 2014 for this indication in adult patients. More recently (29 May 2026), AFREZZA<sup>®</sup> (insulin human) inhalation powder received its first pediatric approval in the USA to improve glycemic control in pediatric patients 6 years of age and older with diabetes mellitus. This article summarizes the milestones in the development of AFREZZA<sup>®</sup> (insulin human) inhalation powder leading to this first pediatric approval for diabetes mellitus.</p>","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":" ","pages":"575-580"},"PeriodicalIF":3.7000,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40272-026-00768-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/8/18 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
引用次数: 0
Abstract
AFREZZA® (insulin human) inhalation powder is a drug-device combination product consisting of a dry powder formulation of rapid-acting recombinant human insulin adsorbed onto proprietary Technosphere® carrier particles, and a breath-powered oral inhaler. The powder is aerosolized and delivered to the lungs by the patient inhaling through the device. AFREZZA® (insulin human) inhalation powder has been developed by MannKind Corporation to improve glycemic control in patients with diabetes mellitus and received its first approval in the USA in 2014 for this indication in adult patients. More recently (29 May 2026), AFREZZA® (insulin human) inhalation powder received its first pediatric approval in the USA to improve glycemic control in pediatric patients 6 years of age and older with diabetes mellitus. This article summarizes the milestones in the development of AFREZZA® (insulin human) inhalation powder leading to this first pediatric approval for diabetes mellitus.
期刊介绍：
Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes:
-overviews of contentious or emerging issues.
-comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development.
-practical reviews covering optimum drug management of specific clinical situations.
-systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement.
-Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population.
-original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies.
Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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