The FDA has approved Afrezza (insulin human) inhalation powder for use in children and adolescents aged 6 and older living with Type 1 and Type 2 diabetes.
Afrezza, created by MannKind Corp, is an ultra-rapid-acting inhaled insulin administered at mealtime through a drug-delivery platform, according to a May 29 news release from the drugmaker. The approval expands the therapy’s availability beyond adults and introduces a new inhaled mealtime insulin option for pediatric patients and caregivers.
The approval was supported by results from the phase 3 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, the drugmaker said.
More than 350,000 children and adolescents in the U.S. are living with diabetes, most of whom have Type 1 diabetes and require insulin therapy. MannKind said eligible patients can access Afrezza for $35 or less per month through its patient support program.
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