FDA approves MannKind’s Afrezza® inhaled insulin for children aged 6+, expanding its label beyond adults. Backed by INHALE-1 trial data, Afrezza becomes the first ultra rapid-acting inhaled insulin available for pediatric use, offering needle-free mealtime dosing with pulmonary safety monitoring.
Written By: Disha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved MannKind Corporation’s Afrezza® (insulin human) Inhalation Powder for children and adolescents aged six years and older with type 1 or type 2 diabetes. The decision extends Afrezza’s use beyond adults, marking the first time an ultra rapid-acting inhaled insulin is available for pediatric patients.
More than 350,000 children and adolescents in the United States live with diabetes, most of whom have type 1 diabetes requiring lifelong insulin therapy. The approval provides families with a needle-free mealtime insulin option that may help reduce the burden of multiple daily injections.
Technosphere Platform Enables Rapid Insulin Delivery
Afrezza delivers insulin via the lungs using MannKind’s proprietary Technosphere® drug-delivery platform. The inhaled powder rapidly enters systemic circulation, producing an ultra-rapid insulin response that more closely mirrors physiologic insulin release at mealtime.
Unlike traditional rapid-acting injectable insulins that often require dosing before meals, Afrezza is administered at the start of eating, offering greater flexibility for unpredictable meals, snacks, school activities, and sports.
INHALE-1 Trial and Safety Review
The FDA’s decision was supported by data from the pivotal Phase 3 INHALE-1 trial (NCT04974528), which evaluated Afrezza in pediatric patients with diabetes. The agency also reviewed additional safety, efficacy, and long-term exposure data generated during more than two decades of inhaled insulin development.
According to MannKind, the totality of evidence demonstrated a safety and efficacy profile that supported use in children and adolescents aged six years and older. No new major safety concerns were identified during the regulatory review.
Afrezza carries a boxed warning for acute bronchospasm in patients with chronic lung disease, including asthma and chronic obstructive pulmonary disease (COPD). Pulmonary function monitoring remains an important consideration when prescribing the therapy to pediatric patients.
Expanding Treatment Options for Families
Diabetes specialists have long recognized the challenges of mealtime insulin management in children, where food intake, physical activity, and daily routines often vary significantly. The availability of an inhaled insulin may help clinicians align treatment more closely with real-world pediatric lifestyles while reducing the burden associated with injections.
According to MannKind, the approval addresses a longstanding need for alternatives to multiple daily mealtime injections and expands Afrezza into a large pediatric diabetes population.
Chief Executive Officer Michael Castagna highlighted the therapy’s ability to be administered at the moment of eating without extensive pre-meal planning, offering families greater flexibility in daily diabetes management.
Implications for Pediatric Diabetes Care
Afrezza is immediately available for eligible pediatric patients following FDA approval. MannKind stated that commercially insured patients may access the therapy for $35 or less per month through available support programs.
Originally approved in 2014 for adults with diabetes, Afrezza is now the only FDA-approved ultra rapid-acting inhaled insulin available for both adult and pediatric patients. The label expansion opens a new commercial opportunity for MannKind and may support broader adoption of inhaled insulin as clinicians seek less burdensome treatment options for younger patients. The company is expected to focus on physician education, payer access, and pediatric market uptake following the approval.
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About the Writer
Disha Sanjay Jadhav (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.