MannKind Secures FDA Approval for Afrezza in Pediatric Diabetes
MannKind Corporation has received US Food and Drug Administration (FDA) approval for Afrezza® (insulin human) Inhalation Powder for children and adolescents aged six years and older with type 1 or type 2 diabetes.
The approval expands Afrezza’s indication beyond adults, offering a needle-free mealtime insulin option for younger patients.
Afrezza is an ultra rapid-acting inhaled insulin delivered through MannKind’s proprietary Technosphere® platform, enabling rapid absorption through the lungs and helping to mimic the body’s natural insulin response during meals.
The FDA decision was supported by findings from the pivotal INHALE-1 clinical trial, along with additional long-term safety and efficacy data gathered from inhaled insulin studies conducted over the past two decades.
With more than 350,000 children and adolescents living with diabetes in the United States, the approval provides healthcare professionals and families with an additional treatment option designed to support flexible meal-time dosing and everyday diabetes management.
Afrezza was first approved for adults in 2014 and is now the only FDA-approved ultra-rapid-acting inhaled insulin available for both paediatric and adult patients with diabetes mellitus.
