FDA Poised to Expand Afrezza Use to Younger Diabetes Patients

The U.S. Food and Drug Administration is expected to approve MannKind's Afrezza for use in children and adolescents with type 1 or type 2 diabetes, potentially expanding access to the inhaled insulin treatment beyond its current adult patient base. A decision is anticipated around May 29, 2026, with any final action expected shortly thereafter.

Approval would mark a significant label expansion for Afrezza, which is designed to provide rapid-acting insulin through inhalation rather than injection. The decision could offer pediatric endocrinologists and families an additional mealtime insulin option, particularly for patients seeking alternatives to injected rapid-acting insulin.

MannKind would likely be subject to standard post-approval requirements if regulators grant clearance, including safety monitoring and any pediatric-specific labeling conditions. The company and clinicians are expected to focus closely on dosing guidance, pulmonary safety, and appropriate patient selection as the therapy moves toward broader pediatric use.