MannKind Receives FDA Approval for Afrezza in Children Aged 6 and Up
MannKind announced that the U.S. Food and Drug Administration has approved Afrezza Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. This approval expands Afrezza's availability beyond adults, introducing a new mealtime insulin option for pediatric patients and caregivers. The FDA approval is supported by results from the pivotal INHALE-1 clinical trial, along with additional safety, efficacy, and long-term exposure data from studies evaluating inhaled insulin over the past two decades of development.