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 that cause elevated blood glucose, and in children, the most common form requires lifelong insulin therapy. Afrezza is a rapid-acting mealtime insulin delivered as an inhalable powder that is absorbed quickly into the bloodstream. This needle-free option may offer children and adolescents a more convenient way to manage their blood sugar around meals.
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