FDA clears Afrezza pediatric use

May 29, 2026 at 19:12 UTC

3 min read

Inhaled insulin inhaler and box on clinic table after FDA pediatric approval for Afrezza

Key Points

FDA approves Afrezza for children and adolescents aged 6 and older with diabetes
Afrezza becomes an inhaled mealtime insulin option for pediatric type 1 and type 2 patients
MannKind highlights access programs with costs of $35 or less per month for eligible users
Labeling stresses lung-related safety warnings and mandatory spirometry testing

FDA approves pediatric indication for Afrezza

On May 29, 2026, MannKind announced that the U.S. Food and Drug Administration approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 years and older with type 1 and type 2 diabetes. The decision expands Afrezza’s indication beyond adults and establishes it as an inhaled mealtime insulin option for pediatric patients in the United States.

The company describes Afrezza as an ultra rapid-acting inhaled insulin taken at the start of meals. It is administered using a small, portable inhaler that relies on MannKind’s Technosphere delivery platform, which is designed to deliver insulin via the lungs rather than by injection.

Afrezza pediatric use and administration

Afrezza’s newly approved pediatric use covers children and adolescents aged 6 and older with both type 1 and type 2 diabetes. MannKind notes that Afrezza is not known to be safe and effective in children under 6, and the product’s labeling does not include this younger age group.

The therapy is positioned as a mealtime insulin, intended for use at the start of meals to help manage blood glucose. Delivery through a handheld inhaler may offer a non-injectable option for eligible pediatric patients who require rapid-acting insulin around meals.

Safety warnings and lung-related precautions

The approved labeling and company materials emphasize several lung-related safety considerations. MannKind reports that a small lung-cancer signal was observed in prior studies, which is reflected in the safety information provided with Afrezza.

The materials also cite reports of sudden lung problems, or bronchospasm, in some patients with asthma who used Afrezza. As a result, Afrezza is contraindicated in patients with chronic lung disease, and prescribers are instructed not to use the product in this population.

Before prescribing Afrezza, healthcare providers are required to perform a breathing test, or spirometry, to assess lung function. This requirement is included in the approved labeling as part of the risk management around potential pulmonary side effects.

Access, affordability and support programs

MannKind states that eligible patients can access Afrezza for $35 or less per month. The company indicates this pricing is intended to support affordability for patients who qualify under its access criteria.

To help navigate coverage and access, MannKind points to its MannKind Cares program. The company says this program will provide dedicated support for patients, caregivers and healthcare providers who are seeking information about insurance coverage, financial assistance and product access.

Investor call and communication plans

MannKind plans to discuss the pediatric approval on a live conference call and webcast scheduled for 4:30 p.m. Eastern on May 29, 2026. The company lists CEO Michael Castagna, PharmD, and Kevin Kaiserman, MD, as presenters on the call.

According to the announcement, the live audio webcast and a recorded replay will be accessible via MannKind’s investor website. The recorded version is expected to remain available for approximately 90 days, providing investors and other stakeholders with extended access to management’s remarks on the pediatric approval and related plans.

Key Takeaways

Afrezza’s FDA approval for patients aged 6 and older broadens treatment options by adding an inhaled mealtime insulin to pediatric diabetes care.
Mandatory spirometry testing and contraindication in chronic lung disease underline that pulmonary safety is central to Afrezza’s clinical use.
MannKind is pairing the new indication with cost caps for eligible patients and a dedicated support program, signaling a focus on access and adherence.
The company’s same-day investor call and extended webcast replay highlight the strategic importance of the pediatric label expansion for stakeholders.