for diabetes mellitus in children and adolescents aged 6 and older
FDA approved expanded labelling for Afrezza (inhaled insulin) to include children and adolescents aged 6 and older with diabetes. Afrezza becomes the first and only inhaled mealtime insulin approved for this pediatric population, offering a needle-free option alongside existing injection and pump regimens.
Diabetes mellitus is a group of metabolic disorders marked by elevated blood glucose, and in children it usually means type 1 diabetes, which requires lifelong insulin therapy to keep blood sugar under control. Afrezza is a powdered insulin that is breathed into the lungs through an inhaler, where it absorbs quickly into the bloodstream and peaks faster than injected insulin. Because it mimics the body's natural mealtime insulin surge without a needle, it may offer children and adolescents a simpler alternative to injections or pumps.
INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog \[RAA\] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin),...
Source: ClinicalTrials.gov