MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes
MannKind (NASDAQ: MNKD) announced the U.S. FDA has accepted its supplemental biologics license application (sBLA) seeking approval of Afrezza inhaled insulin for children and adolescents aged 4–17 with type 1 or type 2 diabetes.
The submission is based on results from the Phase 3 INHALE-1 trial (26-week open-label, randomized) and its 26-week extension; topline results were reported in December 2024. The FDA assigned a PDUFA target action date of May 29, 2026. Full results will be presented at ISPAD in early November. Afrezza is already FDA-approved for adults (18+ since June 2014) and approved in India and Brazil.
MannKind (NASDAQ: MNKD) ha annunciato che la FDA statunitense ha accettato la sua domanda di license biologics supplementare (sBLA) per l'approvazione di Afrezza insulina inalata per bambini e adolescenti di età 4–17 con diabete di tipo 1 o tipo 2.
La presentazione si basa sui risultati dello studio di fase 3 INHALE-1 (26 settimane aperte, randomizzate) e sulla sua estensione di 26 settimane; i risultati principali sono stati comunicati nel dicembre 2024. La FDA ha assegnato una data obiettivo di azione PDUFA del 29 maggio 2026. I risultati completi saranno presentati a ISPAD all'inizio di novembre. Afrezza è già approvata dalla FDA per adulti (18+ da giugno 2014) e approvata in India e Brasile.
MannKind (NASDAQ: MNKD) anunció que la FDA de EE. UU. ha aceptado su solicitud suplementaria de licencia de productos biológicos (sBLA) para la aprobación de Afrezza insulina inhalada para niños y adolescentes de 4–17 años con diabetes tipo 1 o tipo 2.
La presentación se basa en los resultados del ensayo de Fase 3 INHALE-1 (26 semanas, abierto, aleatorizado) y su extensión de 26 semanas; los resultados principales se informaron en diciembre 2024. La FDA asignó una fecha objetivo de acción PDUFA del 29 de mayo de 2026. Los resultados completos se presentarán en ISPAD a principios de noviembre. Afrezza ya está aprobada por la FDA para adultos (18+ desde junio de 2014) y aprobada en India y Brasil.
MannKind (NASDAQ: MNKD) 은 미국 FDA 가 보완 생물학적 제제 면허 신청(sBLA) 을 받아 Afrezza 흡입 인슐린 을 4–17 세의 제1형 또는 제2형 당뇨 아동·청소년에게 승인을 모색했다고 발표했다.
제출은 3상 INHALE-1 시험(26주 열린 라벨, 무작위 비교) 및 26주 연장을 기반으로 한다; 주요 결과는 2024년 12월에 보고되었다. FDA는 2026년 5월 29일의 PDUFA 목표 조치일을 지정했다. 전체 결과는 11월 초 ISPAD에서 발표될 예정이다. Afrezza 는 이미 성인(2014년 6월 이후 18세 이상)용으로 FDA에 승인을 받았으며 인도와 브라질에서도 승인되어 있다.
MannKind (NASDAQ : MNKD) a annoncé que la FDA américaine a accepté sa demande supplémentaire de licence biologics (sBLA) visant l'approbation de Afrezza insuline inhalée pour les enfants et adolescents âgés de 4 à 17 ans atteints de diabète de type 1 ou de type 2.
La soumission est basée sur les résultats de l'essai de phase 3 INHALE-1 (26 semaines en ouvert, randomisé) et son extension de 26 semaines ; les résultats préliminaires ont été communiqués en décembre 2024. La FDA a attribué une date cible d'action PDUFA au 29 mai 2026. Les résultats complets seront présentés lors de l'ISPAD au début du mois de novembre. Afrezza est déjà approuvée par la FDA pour les adultes (18+ depuis juin 2014) et approuvée en Inde et au Brésil.
MannKind (NASDAQ: MNKD) gab bekannt, dass die US-amerikanische FDA seine ergänzende Biologics-Lizenzanwendung (sBLA) zur Genehmigung von Afrezza inhalierteinsulin für Kinder und Jugendliche im Alter von 4–17 Jahren mit Typ-1- oder Typ-2-Diabetes akzeptiert hat.
Der Antrag basiert auf den Ergebnissen der Phase-3-Studie INHALE-1 (26 Wochen offene, randomisierte Studie) und deren 26-wöchiger Verlängerung; die Topline-Ergebnisse wurden im Dezember 2024 berichtet. Die FDA setzte ein PDUFA-Zieltermin für die Entscheidung auf den 29. Mai 2026. Vollständige Ergebnisse werden auf der ISPAD-Konferenz Anfang November vorgestellt. Afrezza ist bereits FDA-zugelassen für Erwachsene (18+ seit Juni 2014) und in Indien und Brasilien zugelassen.
أعلنت MannKind (المدرج في ناسداك: MNKD) أن إدارة الغذاء والدواء الأمريكية قد قبلت طلبها الإضافي لرخصة بيولوجية (sBLA) للموافقة على Afrezza الإنسولين المستنشق للاستخدام لدى الأطفال والمراهقين الذين تتراوح أعمارهم بين 4–17 عامًا المصابين بالسكري من النوع 1 أو النوع 2.
يعتمد الطلب على نتائج تجربة المرحلة 3 INHALE-1 (26 أسبوعًا مفتوحة، عشوائية) وتوسعها لمدة 26 أسبوعًا؛ تم الإبلاغ عن النتائج الأولية في ديسمبر 2024. حدّدت FDA تاريخ إجراء هدف PDUFA وهو 29 مايو 2026. ستُعرض النتائج الكاملة في ISPAD في أوائل نوفمبر. Afrezza مطلقة حاليًا من FDA للكبار (18+ منذ يونيو 2014) ومُعتمدة في الهند والبرازيل.
MannKind (NASDAQ: MNKD) 宣布，美国食品药品监督管理局已接受其补充生物制剂许可申请（sBLA），寻求批准 Afrezza 吸入式胰岛素 用于 4–17 岁的儿童和青少年，患有1型或2型糖尿病。
该提交基于3期 INHALE-1 试验（26周开放标签、随机分组）及其26周延伸；初步结果于 2024年12月 公布。FDA 指定了 2026年5月29日 的 PDUFA 目标行动日期。完整结果将于11月初在 ISPAD 上公布。Afrezza 已经获成人（自2014年6月起18岁及以上）FDA 批准，并在印度和巴西获批。
- FDA accepted sBLA for Afrezza in ages 4–17
- PDUFA target date May 29, 2026
- Phase 3 INHALE-1 26-week topline reported Dec 2024
- Extension phase included MDI patients switching to Afrezza
- Not yet approved for pediatric use pending FDA decision
- INHALE-1 was open-label, which can affect bias assessment
- Full results pending until ISPAD presentation in early November
Insights
MannKind's FDA sBLA acceptance for pediatric Afrezza is a clearly positive regulatory milestone with a
Acceptance for review signals the FDA found the submission complete enough to begin full evaluation. The sBLA rests on the Phase 3 INHALE-1 program in children and adolescents aged 4–17 and includes a 26-week randomized comparison versus multiple daily injections and a 26-week extension safety dataset. If approved, Afrezza would become a novel needle-free prandial insulin option for pediatric patients, marking a distinct route of administration relative to existing injections or pumps.
Outcome depends on the strength of the pediatric safety and efficacy data, and on any FDA questions that arise during review. The company plans to present full INHALE-1 results at ISPAD in early November, which is a near-term data catalyst. Key items to watch are the full safety tables and glycemic outcome details at ISPAD and any FDA communications before the
- If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy
- sBLA submission based on data from the Phase 3 INHALE-1 study
- PDUFA target action date of May 29, 2026
WESTLAKE VILLAGE, Calif. and DANBURY, Conn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.
“Today’s milestone brings us one step closer to offering young children and teenagers living with diabetes a potential alternative therapy to multiple daily injections or an insulin pump system,” said Dr. Kevin Kaiserman, M.D., Senior Vice President, Therapeutic Area Head, Endocrine Diseases at MannKind Corporation. “Inhaled insulin has been available to adults for over a decade, and we are excited about the potential of adding this treatment choice for the pediatric population.”
The sBLA is based on results from the Phase 3 INHALE-1 study in children and adolescents between the ages of 4-17 who are living with either type 1 or type 2 diabetes. The 26-week open-label, randomized clinical trial evaluated Afrezza in combination with basal insulin vs. multiple daily injections (MDI) with basal insulin. Six-month topline results from INHALE-1 were reported in December 2024. The submission also included safety data from the study’s 26-week extension phase in which all remaining MDI patients switched to Afrezza. Full results will be shared at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November.
Afrezza was first approved by the FDA for adults (age 18+) in June 2014 and is also approved in India and Brazil. It is recognized as part of the American Diabetes Association’s Standards of Care.
About Afrezza
Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.
Important Safety Information
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
- Acute bronchospasm has been observed in Afrezza-treated patients with asthma and COPD
- Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
- Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on Afrezza.com/safety.
About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.
With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.
Learn more at mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, such as statements about a potential regulatory action date, the planned presentation of scientific data and the potential expanded patient population of Afrezza. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining the expanded indication as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
AFREZZA and MANNKIND are registered trademarks of MannKind Corporation.
For MannKind: Media Relations Christie Iacangelo Email: media@mnkd.com Investor Relations Ana Kapor Email: ir@mnkd.com
FAQ
What did MannKind announce about Afrezza for children (MNKD) on October 13, 2025?
What clinical data supports MNKD's pediatric sBLA for Afrezza?
When will the FDA decide on MannKind's pediatric Afrezza application (MNKD)?
Will MannKind share full pediatric Afrezza results before the FDA decision (MNKD)?
Is Afrezza already approved for adults and other countries (MNKD)?
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